17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery
This study is currently recruiting patients.
Sponsored by: |
Mayo Clinic Cancer Center
|
Information provided by: |
National Cancer Institute (NCI) |
Purpose
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 17-N-allylamino-17-demethoxygeldanamycin in treating patients who have
solid tumors that cannot be removed by surgery.
Condition
|
Treatment or Intervention |
Phase |
adult Hodgkin's lymphoma adult T-cell leukemia and lymphoma adult non-Hodgkin's lymphoma adult solid tumor Cutaneous T-Cell Lymphoma mycosis fungoides and Sezary syndrome
|
Drug: 17-N-allylamino-17-demethoxygeldanamycin Procedure: chemotherapy
|
Phase I
|
MedlinePlus related topics: Hodgkin's Disease; Immune System and Disorders; Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood; Lymphoma; Viral Infections
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of 17-N-Allylamino-17-Demethoxygeldanamycin (17-AAG) in Patients With Unresectable Solid Tumors or Relapsed
Lymphoma
Further Study Details:
OBJECTIVES:
- Determine the maximum tolerated dose and dose-limiting toxicity of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG), administered
at 2 different dosing schedules, in patients with unresectable solid tumors.
- Determine the pharmacokinetics of this drug in these patients.
- Assess the effect of this drug on heat shock protein chaperone complex components and client proteins in lymphoma tissue obtained
pre- and post-treatment in patients with relapsed lymphoma.
- Determine any response to this drug in these patients.
OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 treatment groups.
- Group I: Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1 hour on days 1, 8, and 15. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.
- Group II: Patients receive 17-AAG IV over 1 hour on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease
progression or unacceptable toxicity. Cohorts of 1-6 solid tumor patients 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 6 patients experience dose-limiting
toxicity.
Once the MTD is determined, 10 lymphoma patients are accrued and treated as in group II at the MTD.
Patients are followed for 3 months.
PROJECTED ACCRUAL: A total of 58-130 patients (30-72 for group I and 28-58 for group II) will be accrued for this study within
2 years.
Eligibility
Ages Eligible for Study:
18 Years and above,
Genders Eligible for Study:
Both
DISEASE CHARACTERISTICS:
- One of the following diagnoses:
- Histologically or cytologically confirmed solid tumor
- Unresectable disease
- Hodgkin's or non-Hodgkin's lymphoma
- Relapsed disease
- Failed at least 1 prior therapy
- Neoplastic cells are accessible through biopsy
- No known standard therapy that is potentially curative or definitely capable of extending life expectancy exists
- No CNS metastases
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9 g/dL
Hepatic:
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- AST no greater than 2.5 times ULN
- Alkaline phosphatase no greater than 2 times ULN (5 times ULN if liver involvement)
Renal:
- Creatinine no greater than 1.25 times ULN OR
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No New York Heart Association class III or IV heart disease
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective nonhormonal contraception
- No uncontrolled infection
- No seizure disorder
- No history of serious allergic reaction to eggs
PRIOR CONCURRENT THERAPY: Biologic therapy:
- More than 4 weeks since prior immunotherapy
- More than 4 weeks since prior biologic therapy
- No concurrent immunotherapy
- No concurrent routine or prophylactic use of a colony-stimulating factor (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])
Chemotherapy:
- More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered from acute and reversible
toxic effects
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent birth control pills
- No concurrent steroids as anti-emetics
Radiotherapy:
- More than 4 weeks since prior radiotherapy
- No prior radiotherapy to more than 25% of the bone marrow
- No prior radiopharmaceuticals
- No concurrent radiotherapy
Surgery:
Other:
- No concurrent 3A4 enzyme inhibitors (e.g., verapamil, erythromycin, miconazole, or ketoconazole)
- No concurrent investigational ancillary therapy
- No concurrent enrollment in another study involving a pharmacologic agent (e.g., drugs, biologics, immunotherapy approaches,
or gene therapy) for symptom control or therapeutic intent
Location
and Contact
Information
Minnesota Mayo Clinic Cancer Center, Rochester,
Minnesota,
55905,
United States; Recruiting
Study chairs or principal investigators
Charles Erlichman, MD, Study Chair, Mayo Clinic Cancer Center
David O. Toft, PhD, Mayo Clinic Cancer Center
Joel M. Reid, PhD, Mayo Clinic Cancer Center
Matthew M. Ames, PhD, Mayo Clinic Cancer Center
Thomas E. Witzig, MD, Mayo Clinic Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers:
CDR0000067283; MAYO-990102; NCI-T99-0058
Record last reviewed:
February 2004
Record first received:
December 10, 1999
ClinicalTrials.gov Identifier:
NCT00004075Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-11-08