Status:
COMPLETED
Fludarabine Followed by Vaccine Therapy and White Blood Cell Infusions in Treating Patients With Unresectable or Metastatic Melanoma
Lead Sponsor:
Providence Cancer Center, Earle A. Chiles Research Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Detailed Description
OBJECTIVES: Primary * Determine the toxicity and immune effects of vaccination comprising modified gp100 peptide (gp100:209-217\[210M\]), Montanide ISA-51, and keyhole limpet hemocyanin followed by ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00091143
Start Date
July 1 2004
End Date
March 1 2010
Last Update
April 4 2013
Active Locations (1)
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1
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967