Trial · NCT00085423
Cyclophosphamide, Fludarabine, and High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma
NCT00085423, Phase 2, Completed, Dartmouth-Hitchcock Medical Center; results first posted 2013-04-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cyclophosphamide, Fludarabine, and High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma. Trials, record NCT00085423. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00085423
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cyclophosphamide, Fludarabine, and High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma
- NCT number
- NCT00085423
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Conditions
- Melanoma (Skin)
- Interventions
- aldesleukin, sargramostim, cyclophosphamide, fludarabine phosphate
- First posted
- 2004-06-11
- Last updated
- 2013-04-10
- Results first posted
- 2013-04-10
- Limitations and caveats
This was the first stage of a two-stage phase II study and continuation to next stage required 4 of 18 particpant having an objective response. Only 3 objective responses were noted and the study was terminated at stage 1.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of partiCIPANTS WITH OBJECTIVE RESPONSE AS MEASURED BY RECIST | Response at 12 weeks | Objective response as measured by radiological and physical examination using RECIST criteria. |
| Secondary | Number of Participants With Lymphocyte Recovery as Measured by Blood Count | on days 1-15, weekly for 2 weeks, and then every 2-3 months | Lymphocyte recovery to a greater than 1000 cells/mcL was determined by differential peripheral blood cell counts on sequential days as noted in time frame. |
| Secondary | Time to Progression as Measured by RECIST | From date of randomization until the first date of documented progression or date of death from any cause, which ever came first, assessed up till 100 months | Clinical outcome used the National Cancer Institute's Response Evaluation Criteria in Solid Tumors (RECIST)1.0. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of partiCIPANTS WITH OBJECTIVE RESPONSE AS MEASURED BY RECIST | Response at 12 weeks | Response was determined by physical examination and radiologic testing. Percent of the total number of patients treated was calculated. | participants | NUMBER |
| SECONDARY | Number of Participants With Lymphocyte Recovery as Measured by Blood Count | on days 1-15, weekly for 2 weeks, and then every 2-3 months | each patient's differential blood counts were used to determine the time of recovery to the lower limit of normal lymphocytes in the peripheral blood. | participants | NUMBER |
| SECONDARY | Time to Progression as Measured by RECIST | From date of randomization until the first date of documented progression or date of death from any cause, which ever came first, assessed up till 100 months | years | MEAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of partiCIPANTS WITH OBJECTIVE RESPONSE AS MEASURED BY RECIST | Group 1 | 3 | participants | ||
| Number of Participants With Lymphocyte Recovery as Measured by Blood Count | Group 1 | 18 | 1000 to 4000 | participants | |
| Time to Progression as Measured by RECIST | Group 1 | .3 | 95% Confidence Interval .2 to .4 | years |
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 | Lymphodepleting Chemotherapy + High Dose Interleukin-2 | 20 | |
| Overall Study | COMPLETED | Lymphodepleting Chemotherapy + High Dose Interleukin-2 | 18 | |
| Overall Study | NOT COMPLETED | Lymphodepleting Chemotherapy + High Dose Interleukin-2 | 2 |
Source ClinicalTrials.gov
Adverse events2
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 | thrombocytopenia | Blood and lymphatic system disorders | Group 1 | 4 | 18 | 18 |
| serious | anemia | Blood and lymphatic system disorders | Group 1 | 8 | 18 | 18 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 | ||
| Total, other adverse events | Group 1 | 4 | 18 |
| Total, serious adverse events | Group 1 | 8 | 18 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20124177 | RESULT |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA023108 | Cancer Center Support Grant | DRAGNEV, KONSTANTIN H. | DARTMOUTH COLLEGE | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT00085423
GET https://conductscience.org/api/trials/v1/NCT00085423/registered