Status:
COMPLETED
GM-CSF as Adjuvant Therapy of Melanoma
Lead Sponsor:
Northern California Melanoma Center
Collaborating Sponsors:
Bayer
Melanoma Research Institute
Conditions:
Malignant Melanoma
Eligibility:
All Genders
14+ years
Phase:
PHASE2
Brief Summary
This is a pilot study to describe the immunological responses and clinical outcome associated with administration of recombinant human Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) as surg...
Detailed Description
This is a pilot study to describe the immunological responses and clinical outcome associated with administration of recombinant human Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) as surg...
Eligibility Criteria
Inclusion
- Eligible patients will be males or females with histologically proven melanoma. Patients must have Stage II (T4), III, and IV malignant melanoma surgically resected with no clinical evidence of disease by clinical, laboratory criteria or radiologic examination as defined below.
- Individuals must be at least 14 years of age.
- Pregnant women are not eligible. Men and women will be required to use an effective form of contraception.
- Patients requiring corticosteroid therapy or are receiving other forms of immunotherapy are not eligible.
- Patients may have received immunotherapy for prior disease. They must have completed therapy at least one month prior to study entry. Patients may not have received prior chemotherapy or therapy with GM-CSF. Patients are permitted to receive adjuvant radiation therapy but these patients will not be selected as part of the sub-set undergoing studies of cellular immunologic responses since the radiation could alter these responses. Based on the reults from one randomized, controlled clinical trial, the LEUKINE product labeling contains the following contraindication: "Due to the potential sensitivity of rapidly dividing hematopoietic progenitor cells, LEUKINE should not be administered simultaneously with cytoxic chemotherapy or radiotherapy or within 24 hours preceding or following chemotherapy or radiotherapy. In one controlled study, patients with small cell lung cancer received LEUKINE and concurrent thoracic radiotherapy and chemotherapy or the identical radiotherapy and chemotherapy without LEUKINE. The patients randomized to LEUKINE had significantly higher incidence of adverse events, including higher mortality and a higher incidence of grade 4 infections and grade 3 or 4 thrombocytopenia.28" Other investigators have reported that CM-CSF can be given safely with concurrent radiation therapy. These contrasting results may be related to differences in the patient populations or intensity and/or location of the site of radiotherapy in the body, among other factors. GM-CSF has been administered safely in combination with radiation therapy for treatment of head and neck cancers29,30 and has been used safely during regimens that combine chemotherapy and radiation therapy.31
- Patients must undergo examination for evidence of residual disease, including physical examination, CBC, chemistry panel, CT scan of the chest and abdomen (and pelvis for lower extremity or lower trunk lesions), and single sequence with gadolinium MRI or CT of the brain. A PET scan may be substituted for the CT of the chest and abdomen (and pelvis). These tests must be negative for residual disease before entry into the study.
- Administration of the protocol medication must be initiated within 90 days of the definitive surgical excision rendering the patient NED.
Exclusion
- Patients not meeting Inclusion Criteria described above
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00350597
Start Date
September 1 2004
End Date
July 1 2010
Last Update
July 11 2006
Active Locations (1)
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1
Northern California Melanoma Center
San Francisco, California, United States, 94109