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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

aldesleukin

bryostatin 1

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer, stage III melanoma, stage IV melanoma, recurrent melanoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed cutaneous or mucosal melanoma or renal cell carcinoma Unresectable disease No known uncontrolled CNS metastases CNS metastases allowed only if recently irradiated or known to be controlled PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Hemoglobin at least 8 g/dL WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Absolute lymphocyte count at least 1,000/mm^3 Hepatic: Total bilirubin no greater than 1.5 mg/dL OR Conjugated bilirubin no greater than 0.3 mg/dL AST no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 2 mg/dL Cardiovascular: No myocardial infarction within the past 6 months No uncontrolled hypertension, angina, or congestive heart failure Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 3 months after study No known intolerance to acetaminophen No primary or secondary immunodeficiency No other condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: At least 1 month since prior topical, systemic, or inhaled corticosteroids No concurrent topical, systemic, or inhaled corticosteroids Radiotherapy: See Disease Characteristics Surgery: Not specified

Sites / Locations

Norris Cotton Cancer Center
Massey Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00006022

First Posted

July 5, 2000

Last Updated

December 10, 2015

Sponsor

Virginia Commonwealth University

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00006022

Brief Title

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

Official Title

Phase IA/IB Trial of Modulation of the Biological Response to Interleukin-2 (IL-2) With Bryostatin 1 (BRYO; NSC 339555)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

September 2000 (undefined)

Primary Completion Date

October 2003 (Actual)

Study Completion Date

January 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Virginia Commonwealth University

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Cancer, Melanoma (Skin)

Keywords

stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer, stage III melanoma, stage IV melanoma, recurrent melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Factorial Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

aldesleukin

Intervention Type

Drug

Intervention Name(s)

bryostatin 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed cutaneous or mucosal melanoma or renal cell carcinoma Unresectable disease No known uncontrolled CNS metastases CNS metastases allowed only if recently irradiated or known to be controlled PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Hemoglobin at least 8 g/dL WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Absolute lymphocyte count at least 1,000/mm^3 Hepatic: Total bilirubin no greater than 1.5 mg/dL OR Conjugated bilirubin no greater than 0.3 mg/dL AST no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 2 mg/dL Cardiovascular: No myocardial infarction within the past 6 months No uncontrolled hypertension, angina, or congestive heart failure Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 3 months after study No known intolerance to acetaminophen No primary or secondary immunodeficiency No other condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: At least 1 month since prior topical, systemic, or inhaled corticosteroids No concurrent topical, systemic, or inhaled corticosteroids Radiotherapy: See Disease Characteristics Surgery: Not specified

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John D. Roberts, MD

Organizational Affiliation

Massey Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

Norris Cotton Cancer Center

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756-0002

Country

United States

Facility Name

Massey Cancer Center

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23219

Country

United States

Kidney Cancer, Melanoma (Skin)

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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