Melanoma (Skin) Clinical Trial
Official title:
A Phase II Study of Temozolomide, Thalidomide, and Lomustine in the Treatment of Advanced Melanoma
Verified date | January 2013 |
Source | Memorial Sloan Kettering Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy, such as temozolomide and lomustine, use different
ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the
growth of cancer by stopping blood flow to the tumor. Combining temozolomide and thalidomide
with lomustine may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and thalidomide
with lomustine in treating patients who have unresectable stage III or stage IV melanoma.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | August 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed metastatic malignant melanoma - Unresectable stage III OR stage IV disease - Ocular, mucosal, and cutaneous melanoma allowed - Measurable disease - Indicator lesions within a prior radiotherapy field must have recent evidence of disease progression - Indicator lesions must be distinct from the surgical and/or radiation changes induced by prior local therapies - No more than 2 symptomatic hemorrhagic lesions in the brain - No hemorrhagic lesion(s) greater than 1 cm in diameter PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 80-100% Life expectancy - Not specified Hematopoietic - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 2 times upper limit of normal (ULN) - SGOT and SGPT no greater than 2 times ULN - Alkaline phosphatase no greater than 2 times ULN - Lactic dehydrogenase no greater than 2 times ULN Renal - Creatinine no greater than 2 mg/dL Cardiovascular - No history of severe cardiovascular disease - No myocardial infarction within the past 6 months - No unstable angina - No New York Heart Association class III or IV congestive heart failure - No ventricular arrhythmia - No uncontrolled arrhythmia Gastrointestinal - No frequent vomiting - No other medical condition that would preclude oral medication intake (e.g., partial bowel obstruction) Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception during and for 4 weeks after study participation - HIV negative - No AIDS-related illness - No serious infection requiring IV antibiotics - No other uncontrolled medical illness that would preclude study participation - No other malignancy within the past 2 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or T1a or b prostate cancer meeting all of the following criteria: - Detected incidentally at transurethral resection of the prostate (TURP) - Comprises less than 5% of resected tissue - Prostate-specific antigen normal since TURP PRIOR CONCURRENT THERAPY: Biologic therapy - At least 3 weeks since prior immunotherapy or biologic therapy - No concurrent immunotherapy Chemotherapy - No prior systemic chemotherapy for melanoma - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - At least 3 weeks since prior focused radiotherapy for brain metastases - At least 3 weeks since prior radiosurgery - At least 4 weeks since prior whole brain radiotherapy - At least 3 weeks since prior interstitial brachytherapy - No concurrent radiotherapy Surgery - See Disease Characteristics - At least 3 weeks since prior surgery for brain metastases - At least 3 weeks since prior surgery requiring general anesthesia Other - Recovered from all prior therapies |
Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center | National Cancer Institute (NCI) |
United States,
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04062032 -
Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Subjects at Risk for Melanoma
|
Phase 2 | |
Completed |
NCT03620019 -
Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma
|
Phase 2 | |
Active, not recruiting |
NCT03291002 -
Study of Intratumoral CV8102 in cMEL, cSCC, hnSCC, and ACC
|
Phase 1 | |
Completed |
NCT04534309 -
Behavioral Weight Loss Program for Cancer Survivors in Maryland
|
N/A | |
Completed |
NCT00962845 -
Hydroxychloroquine in Patients With Stage III or Stage IV Melanoma That Can Be Removed by Surgery
|
Early Phase 1 | |
Completed |
NCT00324623 -
Cyclophosphamide and Fludarabine Followed by Cellular Adoptive Immunotherapy and Vaccine Therapy in Patients With Metastatic Melanoma
|
Phase 1 | |
Completed |
NCT00104845 -
Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma
|
Phase 1 | |
Completed |
NCT00096382 -
Cyclophosphamide, Fludarabine, and Total-Body Irradiation Followed By Cellular Adoptive Immunotherapy, Autologous Stem Cell Transplantation, and Interleukin-2 in Treating Patients With Metastatic Melanoma
|
Phase 2 | |
Completed |
NCT00089193 -
Vaccine Therapy With or Without Sargramostim in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma
|
Phase 2 | |
Completed |
NCT00072124 -
Dacarbazine and/or Cisplatin Compared With Complete Metastasectomy in Treating Patients With Stage IV Melanoma
|
Phase 3 | |
Completed |
NCT00072085 -
Immunization With gp100 Protein Vaccine in Treating Patients With Metastatic Melanoma
|
Phase 2 | |
Active, not recruiting |
NCT00039234 -
Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver
|
Phase 3 | |
Completed |
NCT00049010 -
Diagnostic Study to Predict the Risk of Developing Metastatic Cancer in Patients With Stage I or Stage II Melanoma
|
N/A | |
Completed |
NCT00042783 -
Vaccine Therapy in Treating Patients With Stage IV Melanoma
|
Phase 2 | |
Completed |
NCT00005610 -
Study of Aerosolized Sargramostim in Treating Patients With Melanoma Metastatic to the Lung
|
Phase 2 | |
Completed |
NCT00020358 -
Vaccine Therapy in Treating Patients With Melanoma
|
Phase 2 | |
Completed |
NCT00006022 -
Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer
|
Phase 1 | |
Completed |
NCT00006385 -
Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma
|
Phase 2 | |
Recruiting |
NCT03767348 -
Study of RP1 Monotherapy and RP1 in Combination With Nivolumab
|
Phase 2 | |
Withdrawn |
NCT00006126 -
Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery
|
Phase 1 |