Trials / Completed
CompletedNCT00006022
Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer
Phase IA/IB Trial of Modulation of the Biological Response to Interleukin-2 (IL-2) With Bryostatin 1 (BRYO; NSC 339555)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Virginia Commonwealth University · Academic / Other
- Sex
- All
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining bryostatin 1 with interleukin-2 may kill more tumor cells. PURPOSE: Randomized phase I trial to study the effectiveness of interleukin-2 plus bryostatin 1 in treating patients who have melanoma or kidney cancer that cannot be removed during surgery.
Detailed description
OBJECTIVES: * Determine the dose of bryostatin 1 that, when administered in conjunction with low-dose interleukin-2, maximizes in vitro interleukin-2- stimulated peripheral blood stem cell proliferation in patients with melanoma or renal cell carcinoma. * Assess other intermediate markers of immune response in patients treated with this regimen. * Determine tumor responses, response durations, progression-free intervals, and survival of patients treated with this regimen. OUTLINE: This is a randomized, double-blind study. Patients are randomized to one of three bryostatin 1 dose levels. Patients receive interleukin-2 subcutaneously daily on days 1-5 and bryostatin 1 IV over 1 hour on day 1 weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 21 patients will be accrued for this study within 2 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | aldesleukin | |
| DRUG | bryostatin 1 |
Timeline
- Start date
- 2000-09-01
- Primary completion
- 2003-10-01
- Completion
- 2004-01-01
- First posted
- 2003-01-27
- Last updated
- 2015-12-14
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00006022. Inclusion in this directory is not an endorsement.