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A Study of Subcutaneous "CYT 99 007" (Interleukin-7) in Conjunction With Peptide Immunization in Patients With Metastatic Melanoma


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

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Trial Information

A Study of Subcutaneous "CYT 99 007" (Interleukin-7) in Conjunction With Peptide Immunization in Patients With Metastatic Melanoma


OBJECTIVES:

Primary

- Determine the maximum tolerated dose of interleukin-7 (IL-7) when administered with
melanoma peptide vaccine emulsified in Montanide ISA-51 in patients with metastatic
melanoma.

- Determine the safety of this regimen in these patients.

Secondary

- Determine the biological effects of this regimen on T-cell function and phenotype at
various doses and at the optimal biological dose in these patients.

- Determine the pharmacokinetic and pharmacodynamic characteristics of IL-7 in patients
treated with this regimen.

- Determine the antitumor effects of IL-7, in terms of a dose-escalation strategy, in
these patients.

OUTLINE: This is a dose-escalation study of interleukin-7 (IL-7).

Patients receive IL-7 subcutaneously (SC) on days 0, 3, 6, 9, 12, 15, 18, and 21. Patients
also receive melanoma peptide vaccine comprising gp100 antigen and MART-1 antigen emulsified
in Montanide ISA-51 SC on days 0, 7, 14, and 21 in the absence of disease progression or
unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of IL-7 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity. After the MTD is determined, an additional 13
patients are treated at that dose level.

Patients are followed at 1, 2, and 5 weeks, at 3 and 6 months, and then at 1 year.

PROJECTED ACCRUAL: A total of 3-37 patients will be accrued for this study within 1-12.3
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed melanoma

- Metastatic disease

- Measurable or evaluable disease

- Disease progression during or after prior interleukin-2 (IL-2) OR ineligible to
receive high-dose IL-2* OR has disease burden for which IL-2 is not indicated* NOTE:
*If patient did not receive prior IL-2, must have progressed after prior standard
first-line therapy (e.g., metastasectomy for single lesions or dacarbazine)

- HLA-A*0201-positive disease

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 3 months

Hematopoietic

- Absolute neutrophil count > 1,000/mm^3*

- Absolute lymphocyte count ≥ 200/mm^3*

- Platelet count > 100,000/mm^3

- No proliferative hematologic disease NOTE: *For 2 consecutive readings performed on 2
different days

Hepatic

- AST and ALT < 3 times upper limit of normal (ULN)

- PT/PTT ≤ 1.5 times ULN

- Hepatitis B negative

- Positive hepatitis B serology indicative of prior immunization (i.e., positive
for antibody against hepatitis B surface antigen AND negative for antibody
against hepatitis B core antigen) allowed

- Hepatitis C negative

Renal

- Creatinine ≤ 1.4 mg/dL

Cardiovascular

- Ejection fraction > 45% by MUGA for patients ≥ 50 years of age OR with a history of
cardiac disease

- No resting blood pressure > 140/90 mm Hg with standard antihypertensive therapy

Pulmonary

- DLCO/VA and FEV_1 > 50% of predicted on pulmonary function test for smokers OR for
patients with clinical evidence of compromised pulmonary function

- No history of severe asthma

Immunologic

- HIV negative

- No history of autoimmune disease

- No splenomegaly

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other medical or psychiatric disease that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

- More than 4 weeks since prior cytokines

- No prior allogeneic hematopoietic stem cell transplantation

- No concurrent growth factors

- No concurrent monoclonal antibodies

- No other concurrent immunotherapy

- No other concurrent cytokines

- No other concurrent biologic agents

Chemotherapy

- See Disease Characteristics

- No prior intensive myeloablative chemotherapy

- No concurrent chemotherapy

Endocrine therapy

- More than 2 weeks since prior systemic corticosteroids for more than 72 hours in
duration

- No concurrent systemic steroids

Radiotherapy

- Not specified

Surgery

- See Disease Characteristics

- No prior splenectomy

- No prior solid organ transplantation

Other

- More than 4 weeks since prior cytotoxic therapy

- No other concurrent cytotoxic therapy

- No concurrent chronic anticoagulation therapy (e.g., high-dose warfarin, heparin, or
aspirin)

- Concurrent low-dose warfarin (1-2 mg) allowed

- No concurrent chronic medication for asthma

- No concurrent immunosuppressive therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Steven A. Rosenberg, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NCI - Surgery Branch

Authority:

United States: Federal Government

Study ID:

CDR0000387802

NCT ID:

NCT00091338

Start Date:

August 2004

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • recurrent melanoma
  • stage IV melanoma
  • Melanoma

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182