Clinical trial · Interventional
17-DMAG in Treating Patients With Metastatic or Unresectable Solid Tumors or Lymphomas
A Phase I Study Of 17-Dimethylaminoethylamino-17-Demethoxygeldanamycin, (17-DMAG) (NSC 707545) In Patients With Advanced Solid Tumors
NCT00089271CI-TRIAL-00009135completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase I trial is studying the side effects and best dose of 17-DMAG in treating patients with metastatic or unresectable solid tumors or lymphomas. Drugs used in chemotherapy, such as 17-DMAG, work in different ways to stop cancer cells from dividing so they stop growing or die
Conditions
Conditions (50)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Large Cell Lymphoma | Anaplastic Large Cell Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Angioimmunoblastic T-cell Lymphoma | Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type | ALIAS | 0.90 |
| Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | ALIAS | 0.90 |
| Intraocular Lymphoma | Primary Intraocular Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Nodal Marginal Zone B-cell Lymphoma | Nodal Marginal Zone Lymphoma | ALIAS | 0.90 |
| Recurrent Adult Burkitt Lymphoma | Adult Burkitt Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Adult Diffuse Large Cell Lymphoma | — | UNRESOLVED | — |
| Recurrent Adult Diffuse Mixed Cell Lymphoma | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alvespimycin hydrochloride | Drug | Alvespimycin | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (alvespimycin hydrochloride)
- description
- Patients receive 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) IV over 1-6 hours on days 1-3 or 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: alvespimycin hydrochloride
- Other: laboratory biomarker analysis
Primary outcomes (4)
- measure
- Maximum tolerated dose of alvespimycin hydrochloride
- timeFrame
- 21 days
- measure
- Toxicity graded using the NCI CTCAE version 3.0
- timeFrame
- Up to 4 weeks
- measure
- Recommended phase II dose (RP2D) of alvespimycin hydrochloride for future studies determined by toxicity assessments
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed solid tumor or lymphoma * Metastatic or unresectable disease * Standard curative or palliative measures do not exist or are no longer effective * No known brain metastases * Performance status - ECOG 0-2 * Performance status - Karnofsky 60-100% * More than 12 weeks * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9.0 g/dL * ALT and AST ≤ 1.5 times upper limit of normal (ULN) * Bilirubin ≤ normal * Creatinine ≤ 1.25 times ULN * Creatinine clearance ≥ 60 mL/min * QTc \< 450 msec for male patients (470 msec for female patients) * LVEF \> 40% by MUGA * No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row) * No myocardial infarction or active ischemic heart disease within the past year * No New York Heart Association class III or IV congestive heart failure * No poorly controlled angina * No uncontrolled dysrhythmia requiring medication * No left bundle branch block * No history of congenital long QT syndrome * No other significant cardiac disease * Pulse oximetry at rest or on exercise \> 88% * No symptomatic pulmonary disease (e.g., chronic obstructive or restrictive pulmonary disease, etc.) or any of the following are allowed: * Pulmonary disease requiring medication * History of dyspnea, dyspnea on exertion, or paroxysmal nocturnal dyspnea * Patients meeting the Medicare criteria for home oxygen or are on oxygen * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective double barrier contraception 1 week before, during, and for at least 2 weeks after study participation * No uncontrolled illness * No active or ongoing infection * No history of allergic reaction attributed to compounds of similar chemical or biological composition to 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) * No psychiatric illness or social situation that would preclude study compliance * No concurrent routine colony-stimulating factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\]) * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * Concurrent hormonal therapy allowed * At least 4 weeks since prior radiotherapy and recovered * No prior radiation that included the heart in the field (e.g., mantle) * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent anticancer agents or therapies * No concurrent medication that would prolong the QTc interval * No other concurrent investigational agents
References
Publications (0)
Data not yet available
No reference posted for this study.