Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00006022|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 14, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer Melanoma (Skin)||Biological: aldesleukin Drug: bryostatin 1||Phase 1|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Phase IA/IB Trial of Modulation of the Biological Response to Interleukin-2 (IL-2) With Bryostatin 1 (BRYO; NSC 339555)|
|Study Start Date :||September 2000|
|Primary Completion Date :||October 2003|
|Study Completion Date :||January 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006022
|United States, New Hampshire|
|Norris Cotton Cancer Center|
|Lebanon, New Hampshire, United States, 03756-0002|
|United States, Virginia|
|Massey Cancer Center|
|Richmond, Virginia, United States, 23219|
|Study Chair:||John D. Roberts, MD||Massey Cancer Center|