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Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma Clinical research trials and Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma. Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma clinical trial. Participants typically obtain the most effective healthcare available for their Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma  Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma
Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma
For Condition: Stage 4 Melanoma,Recurrent Melanoma
Status: Suspended
Sponsor(s): National Cancer Institute of Canada , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have metastatic or recurrentmalignantmelanoma.
Details: OBJECTIVES: - Determine the efficacy of perifosine, in terms of response rate, in previously untreated patients with metastatic or recurrent malignant melanoma. - Assess the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive oral perifosine daily on days 1-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) or partial response (PR) receive 2 additional courses after documentation of CR or stable PR (i.e., no further tumor shrinkage). Patients are followed at 4 weeks and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed malignant melanoma - Metastatic or recurrent disease deemed incurable by standard therapies - Clinically and/or radiologically documented disease by at least 1 site that is unidimensionally measurable as follows: - At least 20 mm by x-ray or physical exam - At least 10 mm by spiral CT scan - At least 20 mm by non-spiral CT scan - Bone lesions are not considered measurable - Outside previously irradiated area unless evidence of progression or new lesions within irradiated field - No known brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 12 weeks Hematopoietic - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than upper limit of normal (ULN) - AST no greater than 2.5 times ULN Renal - Creatinine no greater than ULN Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior allergic reactions to compounds of similar chemical or biological composition to perifosine - No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix - No ongoing or active infection - No other concurrent uncontrolled medical illness, psychiatric illness, or social situation that would preclude study entry PRIOR CONCURRENT THERAPY: Biologic therapy - At least 3 months since prior adjuvant immunotherapy - No prior immunotherapy for recurrent/metastatic disease Chemotherapy - No prior chemotherapy (including regional therapy) - No other concurrent cytotoxic chemotherapy Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - At least 4 weeks since prior radiotherapy (except for low-dose, nonmyelosuppressive radiotherapy) Surgery - At least 4 weeks since prior major surgery Other - No other concurrent anticancer therapy or investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DonaldErnst, Study Chair, Cancer Care Ontario-London Regional Cancer Centre
McGill University
Montreal, Quebec, H2W 1S6
Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
Canada
Princess Margaret Hospital at University Health Network
Toronto, Ontario, M5G 2M9
Canada
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2L-4M1
Canada
Additional Information:
Study ID Numbers: CDR0000269475; CAN-NCIC-IND156
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053781
Other Stage 4 Melanoma Studies:
1. Vaccine Therapy and Interleukin-12 With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma
2. Interferon alfa Plus Radiation Therapy in Treating Patients With Stage III or Recurrent Melanoma That Has Been Removed by Surgery
3. Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
4. Inhaled Sargramostim in Treating Patients With Melanoma Metastatic to the Lung
5. Temozolomide and Radiation Therapy in Treating Patients With Stage IV Malignant Melanoma With Measurable and Unresectable Cancer Involving the Central Nervous System
Related Studies:
Other Stage 4 Melanoma Clinical Trials
Other Ontario Clinical Trials
Other London Clinical Trials
Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma
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