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

NCT00091338 | Completed Phase 1

• 2 other identifiers: CDR0000387802NCI-04-C-0235
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Melanoma (Skin)

Keywords

recurrent melanoma; stage IV melanoma

Interventions

MART-1 antigen BIOLOGICAL

gp100 antigen BIOLOGICAL

incomplete Freund's adjuvant BIOLOGICAL

recombinant interleukin-7 BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Related Publications (1)

• Rosenberg SA, Sportes 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 CD4+ T-regulatory cells. J Immunother. 2006 May-Jun;29(3):313-9. doi: 10.1097/01.cji.0000210386.55951.c2.

  PMID: 16699374 RESULT

MeSH Terms

Conditions

Melanoma

Interventions

MART-1 Antigen; incomplete Freund's adjuvant; Interleukin-7

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Melanoma-Specific Antigens; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens, Neoplasm; Antigens; Biological Factors; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides

Study Officials

• Steven A. Rosenberg, MD, PhD

  NCI - Surgery Branch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 7, 2004
• First Posted: September 9, 2004
• Study Start: August 1, 2004
• Last Updated: April 30, 2015

Record last verified: 2005-01

Locations

US (1)