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


Phase 1
18 Years
N/A
Not Enrolling
Both
Kidney Cancer, Melanoma (Skin)

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Principal Investigator

John D. Roberts, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Massey Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068034

NCT ID:

NCT00006022

Start Date:

September 2000

Completion Date:

Related Keywords:

  • Kidney Cancer
  • Melanoma (Skin)
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • stage III melanoma
  • stage IV melanoma
  • recurrent melanoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Melanoma

Name

Location

Norris Cotton Cancer CenterLebanon, New Hampshire  03756
Massey Cancer CenterRichmond, Virginia  23298-0037