- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003969
Geldanamycin Analogue in Treating Patients With Advanced Cancer
A Phase I Pharmacokinetic and Pharmacodynamic Study of 17-Allylamino-17-Demethoxygeldanamycin (17-AAG) (NSC 330507) Via Intravenous Administration in Patients With Advanced Malignancies
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase I trial is studying the side effects and best dose of a geldanamycin analogue in treating patients with advanced cancer.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
England
-
London, England, United Kingdom, SW3 6JJ
- Royal Marsden NHS Foundation Trust - London
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Recommended phase II dose of 17-allylamino-17-demethoxygeldanamycin (17-AAG) at 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
---|
Heat shock protein 90 (HSP90) client protein and co-chaperone changes during first course of treatment
|
Pharmacokinetic profile of 17-AAG during the first course of treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ian R. Judson, MA, MD, FRCP, Royal Marsden NHS Foundation Trust
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CRC-PHASE-I-PH1/074
- CDR0000067170 (REGISTRY: PDQ (Physician Data Query))
- NCI-T99-0013
- EU-99055
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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