Fludarabine Followed by Vaccine Therapy and White Blood Cell Infusions in Treating Patients With Unresectable or Metastatic Melanoma

NCT00091143 | Completed Phase 1

• 3 other identifiers: CDR0000383908PPMC-IRB-02-99NCI-6361
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Vaccines made from peptides may make the body build an immune response to kill tumor cells. Infusions of a person's white blood cells may be able to replace immune cells that were destroyed by chemotherapy. Combining fludarabine with vaccine therapy and white blood cell infusions may kill more tumor cells. PURPOSE: This randomized phase I trial is studying the side effects of giving vaccine therapy together with fludarabine and white blood cell infusions and to see how well it works in treating patients with unresectable or metastatic melanoma.

Conditions

Melanoma (Skin)

Keywords

recurrent melanoma; stage III melanoma; stage IV melanoma

Outcome Measures

Primary Outcomes (2)

• Toxicity by clinical and laboratory observation at 1 month

• Antigen-specific T-cell responses by tetramer analysis, ELISPOT, and cytokine flow cytometry periodically

Secondary Outcomes (2)

• Compare 2 different dosing schedules of fludarabine in terms of lymphocyte recovery using a complete blood count periodically

• Tumor regression by standard imaging at study completion

Interventions

gp100 antigen BIOLOGICAL

incomplete Freund's adjuvant BIOLOGICAL

keyhole limpet hemocyanin BIOLOGICAL

fludarabine phosphate DRUG

peripheral blood stem cell transplantation PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed malignant melanoma * Metastatic or unresectable disease * Measurable disease * HLA-A2 positive * Received at least 1 prior immunotherapy and/or chemotherapy regimen for metastatic disease (first 6 patients only) * No known brain metastases unless previously treated with radiotherapy and/or surgery AND is stable for at least 1 month after treatment PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * More than 3 months Hematopoietic * WBC ≥ 3,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Absolute lymphocyte count ≥ 500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL (transfusions allowed) * Hematocrit ≥ 24% * No other active bleeding Hepatic * Bilirubin \< 2 times upper limit of normal (ULN) (unless due to Gilbert's disease) * AST and ALT \< 3 times ULN * Hepatitis B surface antigen negative * Hepatitis C antibody negative Renal * Creatinine \< 2 mg/dL * No uncontrolled hypercalcemia Cardiovascular * No uncontrolled symptomatic congestive heart failure * No unstable angina pectoris * No uncontrolled cardiac arrhythmia * No uncontrolled hypertension Pulmonary * No uncontrolled bronchospasm * No hemoptysis Immunologic * Negative serology for all of the following: * HIV-1 and HIV-2 * HTLV-1 and -2 * Syphilis * Rheumatoid factor \< 43 units/μL * Anti-nuclear antibody \< 11 units/μL * No history of multiple sclerosis, systemic lupus erythematosus, or myasthenia gravis * No primary or secondary immunodeficiency * No active infection * No allergy to seafood or shellfish that would preclude study participation Other * No active gastrointestinal bleeding * No uncontrolled hyperglycemia * No other medical or psychiatric condition or social situation that would preclude study compliance * No other uncontrolled illness * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3-4 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * No prior immunization with gp100:209-217(210M) peptide Chemotherapy * See Disease Characteristics * More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy * More than 2 weeks since prior steroid therapy except replacement steroids or inhaled steroids * No concurrent corticosteroids except replacement steroids * No concurrent dexamethasone Radiotherapy * See Disease Characteristics * More than 2 weeks since prior radiotherapy Surgery * See Disease Characteristics * Recovered from prior surgery Other * No other concurrent investigational agents * No other concurrent anticancer therapy

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

Sponsors & Collaborators

• Providence Cancer Center, Earle A. Chiles Research Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Providence Cancer Center at Providence Portland Medical Center

Portland, Oregon, 97213-2967, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

incomplete Freund's adjuvant; keyhole-limpet hemocyanin; fludarabine phosphate; Peripheral Blood Stem Cell Transplantation

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)

Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Walter J. Urba, MD, PhD

  Providence Cancer Center, Earle A. Chiles Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 7, 2004
• First Posted: September 8, 2004
• Study Start: July 1, 2004
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: April 4, 2013

Record last verified: 2009-08

Locations

US (1)