Phase 2
Completed N=170
Vaccine Therapy With or Without Cyclophosphamide in Treating Patients Who Have Undergone Surgery for Stage II, Stage III, or Stage IV Melanoma
Melanoma (Skin)
Source: ClinicalTrials.gov NCT00118274 ↗
Enrolled (actual)
170
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcomePrimary: Safety of the Peptide Vaccines — 4; 7; 2; 1 Participants
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 the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cyclophosphamide may also stimulate the immune system in different ways and stop tumor cells from growing. Giving vaccine therapy together with cyclophosphamide after surgery may cause a stronger immune response to kill any remaining tumor cells. It may also prevent or delay the recurrence of melanoma.
PURPOSE: This randomized phase I/II trial is studying the side effects of vaccine therapy when given with or without cyclophosphamide and to see how well they work in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of the Peptide Vaccines |
4; 7; 2; 1 | — |
| SECONDARY Immunogenicity (CD8+ T Cell Response to 12 Melanoma Peptides, 12MP) as Measured by Elispot Assay, up to Day 50 |
32; 29; 8; 12 | — |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00118274). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.