Interleukin-7 and Vaccine Therapy in Treating Patients With Metastatic Melanoma

Melanoma (Skin) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00091338
• Other study ID #: CDR0000387802
• Secondary ID: NCI-04-C-0235
• Status: Completed
• Phase: Phase 1
• First received: September 7, 2004
• Last updated: April 29, 2015
• Start date: August 2004

Study information

• Verified date: January 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Interleukin-7 may stimulate a person's white blood cells to kill tumor cells. Vaccines made from peptides may make the body build an immune response to kill tumor cells. Combining interleukin-7 with vaccine therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-7 when given with vaccine therapy in treating patients with metastatic melanoma.

Description:

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.

Other known NCT identifiers

• NCT00088322

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Biological:
• MART-1 antigen

• gp100 antigen

• incomplete Freund's adjuvant

• recombinant interleukin-7

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Rosenberg SA, Sportès C, Ahmadzadeh M, Fry TJ, Ngo LT, Schwarz SL, Stetler-Stevenson M, Morton KE, Mavroukakis SA, Morre M, Buffet R, Mackall CL, Gress RE. IL-7 administration to humans leads to expansion of CD8+ and CD4+ cells but a relative decrease of — View Citation