Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer

Phase 1

Completed

• Conditions: Kidney Cancer; Melanoma (Skin)

• Registration Number: NCT00006022
• Lead Sponsor: Virginia Commonwealth University

Brief 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.

Study Timeline

• Study First Submitted: 2000-07-05
• Study Start: 2000-09
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2003-10
• Study Completion: 2004-01
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-10
• Last Update Posted: 2015-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Trial Locations

Locations (2)

Norris Cotton Cancer Center; 🇺🇸 Lebanon, New Hampshire, United States

Massey Cancer Center; 🇺🇸 Richmond, Virginia, United States