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Chemotherapy in Treating Patients With Refractory Advanced Solid Tumors or Hematologic Cancer 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 Chemotherapy in Treating Patients With Refractory Advanced Solid Tumors or Hematologic Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Chemotherapy in Treating Patients With Refractory Advanced Solid Tumors or Hematologic Cancer Clinical research trials and Chemotherapy in Treating Patients With Refractory Advanced Solid Tumors or Hematologic Cancer 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 Chemotherapy in Treating Patients With Refractory Advanced Solid Tumors or Hematologic Cancer. Chemotherapy in Treating Patients With Refractory Advanced Solid Tumors or Hematologic Cancer 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 Chemotherapy in Treating Patients With Refractory Advanced Solid Tumors or Hematologic Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Chemotherapy in Treating Patients With Refractory Advanced Solid Tumors or Hematologic Cancer 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 > "C" Clinical Trials Conditions > Chemotherapy in Treating Patients With Refractory Advanced Solid Tumors or Hematologic Cancer  Chemotherapy in Treating Patients With Refractory Advanced Solid Tumors or Hematologic Cancer
Chemotherapy in Treating Patients With Refractory Advanced Solid Tumors or Hematologic Cancer
For Condition: Cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , 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 I trial to study the effectiveness 17-N-allylamino-17-demethoxygeldanamycin in treating patients who have refractory advanced solid tumors or hematologic cancers.
Details: OBJECTIVES: - Determine the maximum tolerated dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in patients with refractory or advanced solid tumors or hematologic malignancies. - Evaluate the effects of this drug on the expression of signaling proteins present on an individual patient's cancer at the start of treatment and, if possible, post treatment. OUTLINE: This is a two-phase, dose-escalation, multicenter study. Patients are stratified according to disease (chronic myelogenous leukemia [CML] or Philadelphia chromosome [Ph]+ acute lymphoblastic leukemia [ALL] vs solid tumor). Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 60-90 minutes twice weekly. Courses repeat every 12 weeks in the absence of disease progression (after at least 2 courses for CML or Ph+ ALL patients) or unacceptable toxicity. - Accelerated phase: Single patients receive escalating dose levels of 17-AAG until one patient experiences a first course grade 3 or greater toxicity or two different patients experience grade 2 toxicity during any course. - Standard phase: Cohorts of 3-6 patients in each stratum receive escalating doses of 17-AAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: Approximately 51 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of 1 of the following: - Histologically confirmed advanced primary or malignant solid tumor refractory to standard therapy or for which no curative standard therapy exists - Progressive disease evidenced by 1 of the following: - Non-prostate cancer (including, but not limited to, breast, ovary, head and neck, non-small cell lung, bladder, kidney, colon, stomach, or malignant melanoma) - Development of new lesions or an increase in existing lesions - No increase in a biochemical marker (e.g., carcinoembryonic antigen, CA-15-3, or an increase in symptoms) as sole measure of disease - Prostate cancer (androgen independent) meeting the following criteria: - Progressing metastatic disease on bone scan, CT scan, or MRI - Metastatic disease and rising prostate-specific antigen (PSA) values meeting 1 of the following criteria: - At least 3 rising PSA values obtained at least 1 week apart - 2 rising values more than 1 month apart with at least 25% increase over the range of values - Serum testosterone less than 30 ng/mL - Castrate status should be maintained by medical therapies if orchiectomy has not been performed - Progressive disease must be evident off antiandrogen therapy if received prior to study entry - Registered to protocol MSKCC-9040 - Cytologically confirmed chronic, accelerated, or blastic phase chronic myelogenous leukemia (CML) or Philadelphia chromosome (Ph)-positive acute lymphoblastic leukemia (ALL) refractory to standard therapy or for which no curative therapy exists - Progressive disease evidenced by 1 of the following: - Accelerated or blastic phase disease that is not responsive to standard therapy or loss of hematologic response to imatinib mesylate while remaining in chronic phase for CML - Relapsed or refractory after treatment with standard chemotherapy and imatinib mesylate for Ph-positive ALL - No active CNS or epidural tumor - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Not specified Menopausal status: - Not specified Performance status: - Karnofsky 70-100% Life expectancy: - At least 6 months Hematopoietic: - WBC greater than 3,500/mm^3 - Platelet count greater than 100,000/mm^3 - No restrictions based on peripheral blood counts for CML and Ph-positive ALL Hepatic: - Bilirubin no greater than 1.2 times upper limit of normal (ULN) - AST less than 1.5 times ULN - Prothrombin time normal Renal: - Creatinine no greater than 1.5 times ULN OR - Creatinine clearance greater than 60 mL/min Cardiovascular: - No myocardial infarction within the past 6 months - Ejection fraction greater than 45% by radionuclide cardiac angiography - No ventricular aneurysm or other abnormal wall motion - No reversible defect by thallium stress test if any of the following conditions are present: - Ejection fraction less than 45% on radionuclide angiocardiography - Worrisome but nonexclusive cardiovascular history - Abnormal echocardiogram - Patients with the following history or clinical findings require additional diagnostic testing: - Significant Q waves (greater than 3 mm or greater than one-third of the height of the QRS complex) - ST elevation or depressions of greater than 2 mm that are not attributable to hypertension strain - Absence of regular sinus rhythm - Bundle branch block - Requirement for diuretics for reasons other than hypertension or digoxin for reasons other than atrial fibrillation - Prior mild to moderate congestive heart failure - No New York Heart Association class III or IV heart disease - No angina pectoris - No uncontrolled hypertension or intermittent claudication - No severe debilitating valvular disease Pulmonary: - No severe debilitating pulmonary disease Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No active infection requiring IV antibiotics - No symptomatic peripheral neuropathy grade 2 or higher - No other severe medical conditions that would increase risk for toxicity - No allergy to eggs or egg products PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior biologic therapy (including interferon for CML) and recovered Chemotherapy: - At least 4 weeks since prior chemotherapy (3 days for hydroxyurea for CML or ALL) and recovered - No other concurrent chemotherapy Endocrine therapy: - See Disease Characteristics - At least 4 weeks since prior endocrine therapy and recovered Radiotherapy: - At least 4 weeks since prior radiotherapy and recovered - Concurrent radiotherapy to localized disease sites not being used to evaluate antitumor response allowed - No concurrent radiotherapy to only measurable lesion Surgery: - See Disease Characteristics - Prior orchiectomy allowed - No concurrent surgery Other: - At least 3 days since prior imatinib mesylate for CML or ALL - At least 4 weeks since prior investigational anticancer drugs and recovered - At least 4 weeks since prior palliative treatment for metastatic disease - No concurrent ketoconazole, warfarin, verapamil, miconazole, or erythromycin - No other concurrent investigational drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HowardScher, Study Chair, Memorial Sloan-Kettering Cancer Center
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095
United States
Recruiting Charles Sawyers 310-206-5585
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Howard Scher 646-422-4330
Additional Information:
Study ID Numbers: CDR0000067267; MSKCC-99037,NCI-T99-0035,UCLA-0206019
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004065
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Chemotherapy in Treating Patients With Refractory Advanced Solid Tumors or Hematologic Cancer
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