Clinical trial · Interventional
Fludarabine Followed by Vaccine Therapy and White Blood Cell Infusions in Treating Patients With Unresectable or Metastatic Melanoma
A Pilot Trial of Therapeutic Vaccination With a Modified gp100 Melanoma Peptide (gp100:209-217(210M)), Montanide ISA 51, and KLH With Reconstitution After Chemotherapy to Induce Lymphopenia in Patients With Metastatic Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| gp100 antigen | Biological | — | UNRESOLVED |
| incomplete Freund's adjuvant | Biological | — | UNRESOLVED |
| keyhole limpet hemocyanin | Biological | — | UNRESOLVED |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Toxicity by clinical and laboratory observation at 1 month
- measure
- Antigen-specific T-cell responses by tetramer analysis, ELISPOT, and cytokine flow cytometry periodically
Secondary outcomes (2)
- measure
- Compare 2 different dosing schedules of fludarabine in terms of lymphocyte recovery using a complete blood count periodically
- measure
- Tumor regression by standard imaging at study completion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available