Status:
COMPLETED
Vaccine Therapy With or Without Imiquimod 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
12-120 years
Phase:
PHASE1
Brief Summary
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Biological therapies, such as imiquimod, may stimulate the immune system in different w...
Detailed Description
OBJECTIVES: * Determine the safety of adjuvant transdermal vaccine therapy comprising multi-epitope melanoma peptides (MP), tetanus toxoid helper peptide (TET), and sargramostim (GM-CSF) in combinati...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed melanoma
- Stage II-IV disease
- Has undergone surgical resection within the past 12 months
- No clinical or radiological evidence of disease after surgical resection
- Must have ≥ 1 undissected axillary and/or inguinal lymph node basin
- HLA-A1, -A2, or -A3 positive
- Ineligible for OR refused interferon
- PATIENT CHARACTERISTICS:
- Age
- 12 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 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% (for patients with diabetes)
- No medical contraindication or potential problem that would preclude study compliance
- 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
- Prior vaccinations that resulted in recurrent disease during or after vaccine administration allowed provided the last vaccination was administered more than 12 weeks ago
- Prior multi-epitope melanoma peptide vaccine that resulted in a negative immune response allowed
- 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 vaccine for at least 2 weeks before or after study vaccine administration
- Chemotherapy
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas \[e.g., carmustine or lomustine\])
- No concurrent chemotherapy, including nitrosoureas
- Endocrine therapy
- More than 4 weeks since prior and no concurrent oral or parenteral corticosteroids (e.g., prednisone)
- No prior or concurrent inhaled steroids (e.g., Advair®, Flovent®, Azmacort®)
- Concurrent topical corticosteroids allowed
- Radiotherapy
- More than 4 weeks since prior and no concurrent radiotherapy
- Prior stereotactic radiosurgery allowed provided it was completed within the past 12 months
- Surgery
- See Disease Characteristics
- More than 4 weeks since prior surgical resection of metastatic lesion(s)
- No concurrent surgery requiring general anesthesia
- 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
- No other concurrent immunosuppressive therapy
Exclusion
Key Trial Info
Start Date :
November 4 2004
Trial Type :
INTERVENTIONAL
End Date :
July 28 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00118313
Start Date
November 4 2004
End Date
July 28 2006
Last Update
March 27 2020
Active Locations (1)
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1
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908