Trial · NCT01124734
High Dose Interleukin-2 Followed by Intermittent Low Dose Temozolomide in Patients With Melanoma
NCT01124734, Phase 2, Completed, Milton S. Hershey Medical Center; results first posted 2019-02-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. High Dose Interleukin-2 Followed by Intermittent Low Dose Temozolomide in Patients With Melanoma. Trials, record NCT01124734. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01124734
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- High Dose Interleukin-2 Followed by Intermittent Low Dose Temozolomide in Patients With Melanoma
- NCT number
- NCT01124734
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Milton S. Hershey Medical Center
- Conditions
- Malignant Melanoma
- Interventions
- Interleukin-2, Temozolomide
- First posted
- 2010-05-17
- Last updated
- 2019-02-12
- Results first posted
- 2019-02-12
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Response to High-Dose Interleukin-2 (H-D IL-2) Followed by Low Dose Temozolomide | 2 years | Clinical response was measured using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria categorizing responses as complete response (CR), partial response (PR), minor response (MR), stable disease (SD), or progressive disease (PD). |
| Primary | Duration of Response to High-Dose Interleukin-2 (H-D IL-2) Followed by Low Dose Temozolomide | 8 years | Duration of response is defined as the length (measured in days) from the date of best response to the date of progression (if any), or to the date of last follow-up (if no progression is observed). The duration of response is applicable for those CR/MR/PR/SD subjects only. |
| Primary | Safety and Toxicity of H-D IL-2 Followed by Low Dose Temozolomide | 2 years | Safety and toxicity in this study population was evaluated using the NCI Common Toxicity Criteria. The unit of measure is the number of study participants with one or more unexpected and related (even remotely) SAE. |
| Secondary | Effect of High Dose IL2 Followed by Low Dose Temozolomide on Lymphocyte Subsets (Autoimmune Biomarkers) | 2 years | The effect outcome is measured by the change in percentage of circulating lymphocyte cells (autoimmune biomarkers) that express the noted phenotype. This percentage change is determined by comparing the values obtained within 7 days of participant going off treatment against the baseline values. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Response to High-Dose Interleukin-2 (H-D IL-2) Followed by Low Dose Temozolomide | 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Duration of Response to High-Dose Interleukin-2 (H-D IL-2) Followed by Low Dose Temozolomide | 8 years | Duration of response is applicable for those CR/MR/PR/SD subjects only. | Days | MEAN |
| PRIMARY | Safety and Toxicity of H-D IL-2 Followed by Low Dose Temozolomide | 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Effect of High Dose IL2 Followed by Low Dose Temozolomide on Lymphocyte Subsets (Autoimmune Biomarkers) | 2 years | Of the 17 qualifying participants, 9 underwent baseline (pre-Course 1) testing. Eleven participants consented to and underwent this POST off- treatment testing. Two of the participants tested at Post treatment did not have baseline testing done. | Percentage of Cells | MEAN |
Source ClinicalTrials.gov
Results by group23
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Response to High-Dose Interleukin-2 (H-D IL-2) Followed by Low Dose Temozolomide | Course 1 Cycle 1 | Stable Disease | 17 | Participants | |
| Clinical Response to High-Dose Interleukin-2 (H-D IL-2) Followed by Low Dose Temozolomide | Course 1 Cycle 2 | Stable Disease | 4 | Participants | |
| Clinical Response to High-Dose Interleukin-2 (H-D IL-2) Followed by Low Dose Temozolomide | Course 1 Cycle 1 | Partial Response | 0 | Participants | |
| Clinical Response to High-Dose Interleukin-2 (H-D IL-2) Followed by Low Dose Temozolomide | Course 1 Cycle 2 | Partial Response | 1 | Participants | |
| Clinical Response to High-Dose Interleukin-2 (H-D IL-2) Followed by Low Dose Temozolomide | Course 1 Cycle 1 | Progressive Disease | 0 | Participants | |
| Clinical Response to High-Dose Interleukin-2 (H-D IL-2) Followed by Low Dose Temozolomide | Course 1 Cycle 2 | Progressive Disease | 9 | Participants | |
| Clinical Response to High-Dose Interleukin-2 (H-D IL-2) Followed by Low Dose Temozolomide | Course 1 Cycle 1 | Minor Response | 0 | Participants | |
| Clinical Response to High-Dose Interleukin-2 (H-D IL-2) Followed by Low Dose Temozolomide | Course 1 Cycle 2 | Minor Response | 1 | Participants | |
| Clinical Response to High-Dose Interleukin-2 (H-D IL-2) Followed by Low Dose Temozolomide | Course 1 Cycle 1 | Complete Response | 0 | Participants | |
| Clinical Response to High-Dose Interleukin-2 (H-D IL-2) Followed by Low Dose Temozolomide | Course 1 Cycle 2 | Complete Response | 2 | Participants |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Course 1 Cycle 1 and Cycle 2 | 17 | |
| Overall Study | Completion of Course 1 Cycle 1 | Course 1 Cycle 1 and Cycle 2 | 17 | |
| Overall Study | Initiation of Course 1 Cycle 2 | Course 1 Cycle 1 and Cycle 2 | 17 | |
| Overall Study | COMPLETED | Course 1 Cycle 1 and Cycle 2 | 0 | |
| Overall Study | NOT COMPLETED | Course 1 Cycle 1 and Cycle 2 | 17 |
Source ClinicalTrials.gov
Adverse events88
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 | Hyperbilirubinemia | Hepatobiliary disorders | Course 1 Cycle 1 | 6 | 17 | 20 |
| other | Hyperbilirubinemia | Hepatobiliary disorders | Course 1 Cycle 2 | 1 | 17 | 2 |
| other | Capillary leak syndrome | Vascular disorders | Course 1 Cycle 1 | 10 | 17 | 18 |
| other | Capillary leak syndrome | Vascular disorders | Course 1 Cycle 2 | 4 | 17 | 6 |
| other | Diarrhea | Gastrointestinal disorders | Course 1 Cycle 1 | 9 | 17 | 24 |
| other | Diarrhea | Gastrointestinal disorders | Course 1 Cycle 2 | 4 | 17 | 7 |
| other | Mucositis | Gastrointestinal disorders | Course 1 Cycle 1 | 6 | 17 | 15 |
| other | Mucositis | Gastrointestinal disorders | Course 1 Cycle 2 | 2 | 17 | 4 |
| other | Flu like symptoms | General disorders | Course 1 Cycle 1 | 9 | 17 | 18 |
| other | Flu like symptoms | General disorders | Course 1 Cycle 2 | 3 | 17 | 9 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Course 1 Cycle 1 | 0 | 17 |
| Total, all-cause mortality | Course 1 Cycle 2 | 9 | 17 |
| Total, other adverse events | Course 1 Cycle 1 | 17 | 17 |
| Total, other adverse events | Course 1 Cycle 2 | 17 | 17 |
| Total, serious adverse events | Course 1 Cycle 1 | 1 | 17 |
| Total, serious adverse events | Course 1 Cycle 2 | 1 | 17 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Course 1 Cycle 1 vs Course 1 Cycle 2: Safety and Toxicity of H-D IL-2 Followed by Low Dose Temozolomide | Trial comparisons |
| Course 1 Cycle 1 vs Course 1 Cycle 2: deaths from any cause | Trial comparisons |
| Course 1 Cycle 1 vs Course 1 Cycle 2: serious adverse events | Trial comparisons |
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/NCT01124734
GET https://conductscience.org/api/trials/v1/NCT01124734/results?page=2