Status:
COMPLETED
Vaccine Therapy With or Without Cyclophosphamide in Treating Patients Who Have Undergone Surgery for Stage II, Stage III, or Stage IV Melanoma
Lead Sponsor:
Craig L Slingluff, Jr
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop th...
Detailed Description
OBJECTIVES: Primary * Determine the safety of adjuvant vaccine therapy comprising multi-epitope melanoma peptides (MP) and multi-epitope melanoma helper peptides (MHP) emulsified in Montanide ISA-51...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed melanoma
- Cutaneous, mucosal, or primary melanoma
- Stage IIB-IV disease
- Has undergone surgical resection or stereotactic radiosurgery for malignant melanoma ≥ 1 week but ≤ 6 months ago
- No clinical or radiological evidence of disease after surgical resection or stereotactic radiosurgery by chest x-ray or CT scan\*, abdominal and pelvic CT scan\*, and head CT scan or MRI NOTE: \*Positron emission tomography scan/CT fusion scan may replace scans of the chest, abdomen, and pelvis
- Must have ≥ 2 intact (undissected) axillary and/or inguinal lymph node basins
- HLA-A1, -A2, or -A3 positive AND HLA-DR1, -DR4, -DR11, -DR13, or -DR15 positive
- Ineligible for OR refused interferon
- No ocular melanoma
- Brain metastases allowed provided all of the following criteria are met:
- No more than 3 total brain metastases
- Each metastasis ≤ 2 cm in diameter at the time of study entry
- Each metastasis was completely removed by surgery or treated with stereotactic radiosurgery
- No evidence of brain metastasis progression since the most recent treatment
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-1
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count \> 1,000/mm\^3
- Platelet count \> 100,000/mm\^3
- Hemoglobin \> 9 g/dL
- Hepatic
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin ≤ 2.5 times ULN
- Lactic dehydrogenase ≤ 1.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Hepatitis C negative
- Renal
- Creatinine ≤ 1.5 times ULN
- Cardiovascular
- No New York Heart Association class III or IV heart disease
- Immunologic
- HIV negative
- No known or suspected allergy to any component of the study vaccines
- No autoimmune disorder with visceral involvement
- No prior or active autoimmune disorder requiring cytotoxic or immunosuppressive therapy
- The following immunologic conditions are allowed:
- Laboratory evidence of autoimmune disease (e.g., positive anti-nuclear antibody titer) without symptoms
- Clinical evidence of vitiligo
- Other forms of depigmenting illness
- Mild arthritis requiring non-steroidal anti-inflammatory drugs
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Weight ≥ 110 lbs
- No uncontrolled diabetes
- Hemoglobin A1C \< 7%
- No medical contraindication or potential problem that would preclude study compliance
- No other malignancy except squamous cell or basal cell skin cancer without known metastasis, carcinoma in situ of the breast (ductal or lobular) or cervix, or other successfully treated cancer without distant metastasis with no evidence of recurrence or metastasis for \> 5 years
- No known active addiction to alcohol or drugs
- No recent (within the past year) or ongoing illicit IV drug use
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No prior vaccination with any of the synthetic peptides used in this study
- Prior vaccinations (containing agents other than the synthetic peptides used in this study) that resulted in recurrent disease during or after vaccine administration allowed provided the last vaccination was administered more than 12 weeks ago
- More than 4 weeks since prior and no concurrent interferon (e.g., Intron-A®), interleukins (e.g., Proleukin®), or growth factors (e.g., Procrit®, Aranesp®, or Neulasta®)
- More than 4 weeks since prior and no concurrent allergy desensitization injections
- No influenza vaccines for at least 2 weeks before or after study vaccine administration
- Chemotherapy
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- No concurrent chemotherapy, including nitrosoureas
- Endocrine therapy
- More than 4 weeks since prior and no concurrent oral or parenteral corticosteroids
- No prior or concurrent inhaled steroids (e.g., Advair®, Flovent®, or Azmacort®)
- Prior or concurrent topical corticosteroids allowed
- Radiotherapy
- See Disease Characteristics
- More than 4 weeks since other prior and no concurrent radiotherapy
- Surgery
- See Disease Characteristics
- Other
- More than 4 weeks since prior and no other concurrent investigational agents
- More than 30 days since prior and no concurrent participation in another clinical study
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT00118274
Start Date
March 1 2005
End Date
February 1 2010
Last Update
April 20 2021
Active Locations (3)
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1
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
2
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
3
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908