Trial · NCT00001880
Stem Cell Transplantation for Metastatic Solid Tumors
NCT00001880, Phase 2, Terminated, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2021-11-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Stem Cell Transplantation for Metastatic Solid Tumors. Trials, record NCT00001880. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00001880
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Stem Cell Transplantation for Metastatic Solid Tumors
- NCT number
- NCT00001880
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 42 participants, actual
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Conditions
- Neoplasm Metastasis
- Interventions
- methotrexate, Cyclosporin
- First posted
- 1999-11-04
- Last updated
- 2021-11-10
- Results first posted
- 2021-11-10
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Based on Tumor Response Criteria With Anti-tumor Effect Induce by Graft-versus-tumor Effect. | one year | To identify an anti-tumor effect of allogenic PNSC transplantation by induction of a graft-versus-tumor (GVT) effect in patients with a diversity of metastatic solid tumors, which are refractory to standard therapy. Tumor response assessed as follows: Complete response (CR): disappearance of all signs and symptoms of metastatic disease for a period of at least one month. Partial response (PR): a 50% or greater decrease in the sum of the products of the longest perpendicular diameters of all measured lesions lasting for a period of at least one month. No new metastatic lesions may appear. Stable disease (SD): tumor measurements not meeting the criteria of CR, PR, or PD. Progressive disease (PD): increase of 25% or greater in the sum of the products of the longest perpendicular diameters of all measured lesions compared to the smallest previous measurements, or the development of any new metastatic disease. |
| Secondary | Number of Participants That Achieved Engraftment | Day 100 | Number of participants that achieved engraftment based on blood Chimerism Cluster of differentiation 3 (CD3) analysis that is greater than or equal to 95%. |
| Secondary | Number of Participants Who Received Donor Lymphocyte Infusion to Achieve Tumor Regression or Prevent Graft Failure | 2 years | To evaluate the effects of donor lymphocyte infusion (DLI) and cyclosporine A (CSA) withdrawal on tumor regression in participants who show progressive disease off of CSA and in the absence of grade \> II GVHD, or who are at risk for graft failure due to incomplete donor T-cell engraftment will receive one or more DLI. Tumor response assessed as follows: Complete response (CR): disappearance of signs \& symptoms of metastatic disease at least one month. Partial response (PR): a 50% or greater decrease in the sum of the products of the longest perpendicular diameters of all measured lesions lasting at least one month. No new metastatic lesions may appear. Stable disease (SD): tumor measurements not meeting the criteria of CR, PR, or PD. Progressive disease (PD): increase of 25% or greater in the sum of the products of the longest perpendicular diameters of all measured lesions compared to the smallest previous measurements, or development of new metastatic disease. |
| Secondary | Number of Participants Who Developed Acute GVHD Grade 2 and Higher | Day 100 | Number of participants who developed Acute Graft vs Host Disease (GVHD) Grades I, II, III, IV as defined by CIMBTR criteria for Organ Stages of Acute GVHD. Grades are defined as: Grade I: Skin = Maculopapular rash\< 25% of body surface area (BSA); Liver = Total Bilirubin 2-3 mg/dL; Lower GI = stool output/day is 500-999 mL/day. Grade II: Skin = rash on 25-50 percent body surface area; Liver = Total Bilirubin 3.1-6.0 mg/dL; Lower GI = Diarrhea 1001-1500 mL/day. Grade III: Skin = Rash on \>50% of body surface; Liver = Total Bilirubin 6.1 - 15.0 mg/dL; Lower GI = Diarrhea \> 1500 mL/day. Grade IV: Skin = Generalized erythroderma plus bullous formation; Liver = Total Bilirubin \>15 mg/dL; Lower GI = Severe abdominal pain with or without ileus. Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening. |
| Secondary | Number of Participants Who Developed Chronic GVHD | Day 100 to year 2 | Number of participants who developed Chronic Graft vs Host Disease (GVHD). Chronic GVHD is defined as symptoms that persist or appear after 100 days since the time of stem cell transplantation. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Based on Tumor Response Criteria With Anti-tumor Effect Induce by Graft-versus-tumor Effect. | one year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants That Achieved Engraftment | Day 100 | 9 participants data was not evaluable | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Received Donor Lymphocyte Infusion to Achieve Tumor Regression or Prevent Graft Failure | 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Who Developed Acute GVHD Grade 2 and Higher | Day 100 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Who Developed Chronic GVHD | Day 100 to year 2 | 1 participant passed away prior to day 100 therefore is not evaluable. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Based on Tumor Response Criteria With Anti-tumor Effect Induce by Graft-versus-tumor Effect. | Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors | Complete response (CR) | 0 | Participants | |
| Number of Participants Based on Tumor Response Criteria With Anti-tumor Effect Induce by Graft-versus-tumor Effect. | Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors | Partial response (PR) | 9 | Participants | |
| Number of Participants Based on Tumor Response Criteria With Anti-tumor Effect Induce by Graft-versus-tumor Effect. | Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors | Stable disease (SD): | 5 | Participants | |
| Number of Participants Based on Tumor Response Criteria With Anti-tumor Effect Induce by Graft-versus-tumor Effect. | Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors | Progressive disease (PD) | 28 | Participants | |
| Number of Participants That Achieved Engraftment | Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors | 31 | Participants | ||
| Number of Participants Who Received Donor Lymphocyte Infusion to Achieve Tumor Regression or Prevent Graft Failure | Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors | 16 | Participants | ||
| Number of Participants Who Developed Acute GVHD Grade 2 and Higher | Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors | Grade II | 9 | Participants | |
| Number of Participants Who Developed Acute GVHD Grade 2 and Higher | Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors | Grade III-IV | 11 | Participants | |
| Number of Participants Who Developed Acute GVHD Grade 2 and Higher | Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors | No Acute GVHD | 22 | Participants | |
| Number of Participants Who Developed Chronic GVHD | Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors | 18 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors | 42 | |
| Overall Study | COMPLETED | Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors | 28 | |
| Overall Study | NOT COMPLETED | Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors | 14 |
Source ClinicalTrials.gov
Adverse events17
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hemorrhagic cystitis | Renal and urinary disorders | Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors | 4 | 42 | |
| other | Cytomegalovirus disease | Infections and infestations | Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors | 3 | 42 | |
| serious | Mucositis with fever | Gastrointestinal disorders | Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors | 2 | 42 | 2 |
| serious | Pseudomonas sepsis | Infections and infestations | Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors | 1 | 42 | 1 |
| serious | Parainfluenza pneumonia and septic shock | Infections and infestations | Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors | 1 | 42 | 1 |
| serious | Pulmonary aspergillus | Infections and infestations | Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors | 1 | 42 | 1 |
| serious | Dyspnea with progressive mets to lungs | Respiratory, thoracic and mediastinal disorders | Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors | 1 | 42 | 1 |
| serious | Fecal impaction | Gastrointestinal disorders | Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors | 1 | 42 | 1 |
| serious | Community acquired pneumonia | Infections and infestations | Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors | 1 | 42 | 1 |
| serious | Pneumonia | Infections and infestations | Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors | 1 | 42 | 1 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors | 14 | 42 |
| Total, other adverse events | Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors | 7 | 42 |
| Total, serious adverse events | Stem Cell Transplantation in Patients With Progressive and Incurable Metastatic Solid Tumors | 21 | 42 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00001880
GET https://conductscience.org/api/trials/v1/NCT00001880/registered