17-Dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) in Treating Patients With an Advanced Solid Tumor or Lymphoma
This study is currently recruiting patients.
Purpose
RATIONALE: Drugs used in chemotherapy, such as 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG), work in different
ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of 17-DMAG in treating patients who have an advanced solid tumor or lymphoma.
Condition
|
Treatment or Intervention |
Phase |
adult solid tumor Leukemia Lymphoma small intestine cancer
|
Drug: 17-dimethylaminoethylamino-17-demethoxygeldanamycin Procedure: chemotherapy
|
Phase I
|
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Digestive Diseases; Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood; Lymphoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of 17-Dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) in Patients With an Advanced Solid Tumor or
Lymphoma
Further Study Details:
OBJECTIVES: Primary
- Determine the maximum tolerated dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) in patients with an
advanced malignant solid tumor or lymphoma.
- Determine the dose-limiting toxic effects and toxicity profile of this drug in these patients.
Secondary
- Compare the effects of this drug on heat shock protein 90 (Hsp90) client proteins when assayed in peripheral blood mononuclear
cells (PBMC) vs tumor tissue from patients treated with this drug.
- Correlate disturbances in key signaling pathways with administration of this drug in these patients.
- Determine the dose that alters key proteins in the majority of patients treated with this drug.
- Correlate serum proteomic patterns with target interactions or DMAG clinical effects in patients treated with this drug.
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) IV over 1 hour on days 2, 5, 9, 12, 16, 19,
23, and 26. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 patients receive escalating doses of 17-DMAG 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. Once the MTD is
determined, 10 additional patients are treated at the MTD.
PROJECTED ACCRUAL: Approximately 40 patients 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:
- Histologically confirmed malignant solid tumor OR lymphoma
- Metastatic or unresectable disease
- Standard curative or palliative measures are not available OR are associated with minimal survival benefit
- No known brain metastases
- Treated brain metastases allowed provided they have been stable ≥ 6 months without steroids or anti-seizure medications
PATIENT CHARACTERISTICS: Age
Performance status
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- WBC ≥ 3,000/mm^3
- Hemoglobin > 8 g/dL
Hepatic
- AST and ALT ≤ upper limit of normal
- Bilirubin normal
- PT and PTT normal
Renal
- Creatinine normal OR
- Creatinine clearance ≥ 60 mL/min
Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No orthostatic hypotension > grade 2 (requiring more than brief fluid replacement or other therapy OR with physiological consequences)
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 months after study participation
- HIV negative
- No hyponatremia indicated by sodium < 130 mmol/L
- No known immunodeficiency syndromes
- No history of allergic reaction attributed to compounds of similar chemical or biological composition to 17-dimethylaminoethylamino-17-demethoxygeldanamycin
(geldanamycin or 17-AAG)
- No concurrent uncontrolled illness
- No active or ongoing uncontrolled infection
- No psychiatric illness or social situation that would preclude study compliance
PRIOR CONCURRENT THERAPY: Biologic therapy
- More than 4 weeks since prior biologic therapy and recovered
- No concurrent prophylactic growth factors
Chemotherapy
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin, 8 weeks for UCN-01) and recovered
Endocrine therapy
- See Disease Characteristics
- Concurrent hormonal therapy for prostate cancer allowed provided patient has metastatic disease that has progressed despite
prior hormonal therapy
Radiotherapy
- More than 4 weeks since prior radiotherapy and recovered
Surgery
- At least 4 weeks since prior major surgery
Other
- Concurrent bisphosphonates for any cancer allowed
- Concurrent preventative doses of aspirin or non-steroidal anti-inflammatory drugs allowed
- No concurrent full anticoagulation on a regular basis
- No concurrent prophylactic antiemetics
- No other concurrent investigational agents or therapies
- No other concurrent anticancer agents or therapies
Location
and Contact
Information
Maryland Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda,
Maryland,
20892-1182,
United States; Recruiting
NCI Clinical Studies Support
888-NCI-1937
Study chairs or principal investigators
Barbara A. Conley, MD, Study Chair, National Cancer Institute (NCI)
Patricia S. Steeg, PhD, Principal Investigator, National Cancer Institute (NCI)
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers:
CDR0000377488; NCI-04-C-0218; NCI-6544
Record last reviewed:
August 2004
Record first received:
August 4, 2004
ClinicalTrials.gov Identifier:
NCT00088868Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-29