Geldanamycin Analogue in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00019708
First received: July 11, 2001
Last updated: March 1, 2013
Last verified: March 2013
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Purpose
Phase I trial to study the effectiveness of geldanamycin analogue in treating patients who have advanced solid tumors or non-Hodgkin's lymphoma. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die
| Condition | Intervention | Phase |
|---|---|---|
|
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Nodal Marginal Zone B-cell Lymphoma Non-Hodgkin Lymphoma Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Small Lymphocytic Lymphoma Splenic Marginal Zone Lymphoma Stage IV Adult Burkitt Lymphoma Stage IV Adult Diffuse Large Cell Lymphoma Stage IV Adult Diffuse Mixed Cell Lymphoma Stage IV Adult Diffuse Small Cleaved Cell Lymphoma Stage IV Adult Immunoblastic Large Cell Lymphoma Stage IV Adult Lymphoblastic Lymphoma Stage IV Grade 1 Follicular Lymphoma Stage IV Grade 2 Follicular Lymphoma Stage IV Grade 3 Follicular Lymphoma Stage IV Mantle Cell Lymphoma Stage IV Marginal Zone Lymphoma Stage IV Small Lymphocytic Lymphoma Unspecified Adult Solid Tumor, Protocol Specific |
Drug: tanespimycin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I and Pharmacologic Study of 17-(Allylamino)-17-Demethoxygeldanamycin (AAG, NSC 330507) in Adult Patients With Solid Tumors |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Maximum tolerated dose of tanespimycin [ Time Frame: 28 days ] [ Designated as safety issue: No ]DLT are defined as any greater than or equal to grade 3 non-hematologic toxicity (except for alopecia of any grade, grade 3 nausea or vomiting during less than maximal antiemetic therapy, and grade 3 fever in the absence of neutropenia and infection), any grade 4 hematologic toxicity (except for anemia of any grade), or the inability to resume treatment by day 42 (longer than two week delay) because of drug related toxicity.
Secondary Outcome Measures:
- Biomolecular effects of tanespimycin in normal tissues such as peripheral blood and bone marrow mononuclear cells [ Time Frame: Up to day 5 ] [ Designated as safety issue: No ]Changes in the protein expression of the molecular markers will be assessed by western blot analysis.
- Pharmacokinetics of tanespimycin [ Time Frame: Pre-infusion, 20 minutes, 40, 50, 60 (end of infusion), 70, 80, 95 and 110 minutes, and 2.5, 3, 4, 5, 6.5, 8, 10, 14 and 24 hours ] [ Designated as safety issue: No ]Determined by HPLC with photodiode array detection. The pharmacokinetic parameters that will be determined for parent drug include the maximum plasma concentration (Cmax), time of maximum plasma concentration (Tmax), area under the concentration-time curve (AUC), terminal half-life, clearance and volume of distribution.
| Enrollment: | 45 |
| Study Start Date: | June 1999 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (tanespimycin)
Patients will receive infusions of tanespimycin analogue twice a week in weeks 1 and 3.
|
Drug: tanespimycin
Given IV
Other Name: 17-AAG
|
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose of geldanamycin analogue (AAG) in patients with advanced solid tumors.
II. To determine the toxic effects of this drug in this patient population. III. To determine the biochemical and molecular effects of this drug in normal and accessible tumor tissue in these patients.
IV. To determine the pharmacokinetics of this drug in these patients. V. To assess any antitumor activity of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive geldanamycin analogue (AAG) IV over 1-6 hours once daily on days 1, 4, 15, and 18. Courses repeat every 4 weeks 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 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 10 patients are treated at the MTD.
Patients are followed every 6 weeks.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Criteria:
- Platelet count at least 100,000/mm^3
- No leukemia
- No active CNS involvement with tumor
- ECOG 0-2
- Life expectancy: at least 3 months
- Absolute neutrophil count at least 2,000/mm^3
- No New York Heart Association class III or IV heart failure
- No history of myocardial infarction within the past year
- Bilirubin =< upper limit of normal (ULN)
- AST no greater than 2 times ULN (no greater than 98 U/L)
- No uncontrolled dysrhythmias
- No poorly controlled angina
- No serious ventricular arrhythmia (i.e., ventricular tachycardia (VT) or ventricular fibrillation (VF) >= 3 beats in a row)
- QTc interval =< 450 msec for men or =< 470 msec for women
- LVEF >= 40% by MUGA
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No other serious medical condition that would preclude study participation
- No serious hypersensitivity to egg products
- No concurrent anticancer immunotherapy
- At least 4 weeks since prior chemotherapy and recovered
- No other concurrent anticancer chemotherapy (e.g., cyclophosphamide, doxorubicin, vincristine, and prednisone [CHOP] or mechlorethamine, vincristine, procarbazine, and prednisone [MOPP])
- No concurrent anticancer hormonal therapy
- Concurrent glucocorticoids as antiemetics for nonmalignant disease allowed
- At least 4 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
- No concurrent major surgery
- No concurrent anticancer glucocorticoids
- Creatinine =< ULN or Creatinine clearance at least 60 mL/min
- No concurrent medications that cause QTc prolongation
- Histologically confirmed advanced solid tumor for which no curative therapy exists
- Non-Hodgkin's lymphoma allowed
- No concurrent drugs that interfere with hepatic CYP3A4 metabolism (e.g., grapefruit juice, ketoconazole, fluconazole, itraconazole, cyclosporine, erythromycin, clarithromycin, cimetidine, terfenadine, astemizole, indinavir, or nelfinavir mesylate)
Contacts and Locations More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00019708 History of Changes |
| Obsolete Identifiers: | NCT00001804 |
| Other Study ID Numbers: | NCI-2009-00819, UNMC 170-04 |
| Study First Received: | July 11, 2001 |
| Last Updated: | March 1, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Burkitt Lymphoma Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Immunoblastic Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoma, B-Cell, Marginal Zone Neoplasms Lymphoma, Mantle-Cell Epstein-Barr Virus Infections |
Herpesviridae Infections DNA Virus Infections Virus Diseases Tumor Virus Infections Neoplasms by Histologic Type Neoplasms, Experimental Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell Leukemia, Lymphoid Leukemia |
ClinicalTrials.gov processed this record on May 23, 2013