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Home > "G" Clinical Trials Conditions > Geldanamycin Analogue in Treating Patients With Advanced Cancer  Geldanamycin Analogue in Treating Patients With Advanced Cancer
Geldanamycin Analogue in Treating Patients With Advanced Cancer
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): Cancer Research UK Clinical Groups at Guy's King's & St. Thomas' Hospitals ,
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 of geldanamycin analogue in treating patients who have advanced cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose for a geldanamycin analogue, 17-allylamino-17-demethoxygeldanamycin (AAG), in patients with advanced malignancies. - Determine the toxic effects and dose-limiting toxicity of AAG in this patient population. - Determine the safe dose of AAG for a Phase II study. - Measure the pharmacokinetic and pharmacodynamic profiles of AAG in these patients. - Assess time to tumor progression and any antitumor activity in patients treated with AAG. OUTLINE: This is a dose-escalation study. Patients receive a geldanamycin analogue, 17-allylamino-17-demethoxygeldanamycin (AAG), IV over 15-30 minutes every week. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of AAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 4 weeks. PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically proven malignancies refractory to conventional treatment or for which no standard therapy exists - Primary brain tumor or brain metastases allowed if stable symptoms within 2 weeks prior to study and able to give informed consent PATIENT CHARACTERISTICS: Age: - 18 to 75 Performance status: - WHO 0-2 Life expectancy: - At least 3 months Hematopoietic: - WBC at least 3,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10.0 g/dL - Absolute neutrophil count at least 1,500/mm^3 Hepatic: - Bilirubin less than 1.0 mg/dL - AST and ALT no greater than 2.5 times upper limit of normal if due to liver metastases - No chronic liver disease Renal: - Creatinine less than 1.47 mg/dL OR - Creatinine clearance greater than 60 mL/min Cardiovascular: - No myocardial infarction within the past 6 months - No angina requiring treatment within the past 6 months - No uncompensated coronary artery disease by electrocardiogram or physical examination - No prior transient ischemic attacks, stroke, or peripheral vascular disease - LVEF at least 45% Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 4 weeks after study - No allergy to egg products - No nonmalignant systemic disease that would increase risk - No active uncontrolled infection - No diabetes mellitus with evidence of severe peripheral vascular disease or diabetic ulcers PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunotherapy and recovered Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered - No other concurrent chemotherapy Endocrine therapy: - At least 4 weeks since other prior endocrine therapy and recovered - Concurrent corticosteroids for symptom control allowed if no change in dose requirement within 2 weeks prior to study Radiotherapy: - At least 4 weeks since prior radiotherapy (except for palliative reasons) and recovered - Concurrent radiotherapy allowed for control of bone pain or as indicated Surgery: - Not specified Other: - No other concurrent investigational treatment - No concurrent treatment with drugs interfering with hepatic CYP3A4 metabolism (e.g., grapefruit juice or warfarin)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
IanJudson, Study Chair, Royal Marsden NHS Trust
Royal Marsden NHS Trust - London *Recruiting*
London, England, SW3 6JJ
United Kingdom
Recruiting Ian Judson 44-171-352-8171
Additional Information:
Study ID Numbers: CDR0000067170; CRC-PHASE-I-PH1/074,NCI-T99-0013,EU-99055
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003969
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Acupressure and Acustimulation Wrist Bands for the Prevention of Nausea and Vomiting Caused by Chemotherapy
2. Temozolomide plus PEG-Interferon alfa-2B in Treating Patients With Advanced Solid Tumors
3. Halofuginone Hydrobromide in Treating Patients With Progressive Advanced Solid Tumors
4. Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer
5. Combination Chemotherapy in Treating Patients With Advanced Cancer
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Geldanamycin Analogue in Treating Patients With Advanced Cancer
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