Clinical trial · Interventional
Chemotherapy in Treating Patients With Refractory Advanced Solid Tumors or Hematologic Cancer
A Phase I Trial of 17-N-Allylamino-17-Demethoxy Geldanamycin (17-AAG, NSC #330507) Daily X 5 in Patients With Advanced Cancer Therapeutic Protocol
- 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)
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 17-N-allylamino-17-demethoxygeldanamycin in treating patients with refractory advanced solid tumors or hematologic cancers.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
| Ovarian Cancer |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tanespimycin | Drug | Tanespimycin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following:
* Histologically confirmed advanced primary or malignant solid tumor refractory to standard therapy or for which no curative standard therapy exists
* Progressive disease evidenced by 1 of the following:
* Non-prostate cancer (including, but not limited to, breast, ovary, head and neck, non-small cell lung, bladder, kidney, colon, stomach, or malignant melanoma)
* Development of new lesions or an increase in existing lesions
* No increase in a biochemical marker (e.g., carcinoembryonic antigen, CA-15-3, or an increase in symptoms) as sole measure of disease
* Prostate cancer (androgen independent) meeting the following criteria:
* Progressing metastatic disease on bone scan, CT scan, or MRI
* Metastatic disease and rising prostate-specific antigen (PSA) values meeting 1 of the following criteria:
* At least 3 rising PSA values obtained at least 1 week apart = 2 rising values more than 1 month apart with at least 25% increase over the range of values
* Serum testosterone less than 30 ng/mL
* Castrate status should be maintained by medical therapies if orchiectomy has not been performed
* Progressive disease must be evident off antiandrogen therapy if received prior to study entry
* Registered to protocol MSKCC-9040
* Cytologically confirmed chronic, accelerated, or blastic phase chronic myelogenous leukemia (CML) or Philadelphia chromosome (Ph)-positive acute lymphoblastic leukemia (ALL) refractory to standard therapy or for which no curative therapy exists
* Progressive disease evidenced by 1 of the following:
* Accelerated or blastic phase disease that is not responsive to standard therapy or loss of hematologic response to imatinib mesylate while remaining in chronic phase for CML
* Relapsed or refractory after treatment with standard chemotherapy and imatinib mesylate for Ph-positive ALL
* No active CNS or epidural tumor
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Sex:
* Not specified
Menopausal status:
* Not specified
Performance status:
* Karnofsky 70-100%
Life expectancy:
* At least 6 months
Hematopoietic:
* WBC greater than 3,500/mm\^3
* Platelet count greater than 100,000/mm\^3
* No restrictions based on peripheral blood counts for CML and Ph-positive ALL
Hepatic:
* Bilirubin no greater than 1.2 times upper limit of normal (ULN)
* AST less than 1.5 times ULN
* Prothrombin time normal
Renal:
* Creatinine no greater than 1.5 times ULN OR
* Creatinine clearance greater than 60 mL/min
Cardiovascular:
* No myocardial infarction within the past 6 months
* Ejection fraction greater than 45% by radionuclide cardiac angiography
* No ventricular aneurysm or other abnormal wall motion
* No reversible defect by thallium stress test if any of the following conditions are present:
* Ejection fraction less than 45% on radionuclide angiocardiography
* Worrisome but nonexclusive cardiovascular history
* Abnormal echocardiogram
* Patients with the following history or clinical findings require additional diagnostic testing:
* Significant Q waves (greater than 3 mm or greater than one-third of the height of the QRS complex)
* ST elevation or depressions of greater than 2 mm that are not attributable to hypertension strain
* Absence of regular sinus rhythm
* Bundle branch block
* Requirement for diuretics for reasons other than hypertension or digoxin for reasons other than atrial fibrillation
* Prior mild to moderate congestive heart failure
* No New York Heart Association class III or IV heart disease
* No angina pectoris
* No uncontrolled hypertension or intermittent claudication
* No severe debilitating valvular disease
Pulmonary:
* No severe debilitating pulmonary disease
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active infection requiring IV antibiotics
* No symptomatic peripheral neuropathy grade 2 or higher
* No other severe medical conditions that would increase risk for toxicity
* No allergy to eggs or egg products
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior biologic therapy (including interferon for CML) and recovered
Chemotherapy:
* At least 4 weeks since prior chemotherapy (3 days for hydroxyurea for CML or ALL) and recovered
* No other concurrent chemotherapy
Endocrine therapy:
* See Disease Characteristics
* At least 4 weeks since prior endocrine therapy and recovered
Radiotherapy:
* At least 4 weeks since prior radiotherapy and recovered
* Concurrent radiotherapy to localized disease sites not being used to evaluate antitumor response allowed
* No concurrent radiotherapy to only measurable lesion
Surgery:
* See Disease Characteristics
* Prior orchiectomy allowed
* No concurrent surgery
Other:
* At least 3 days since prior imatinib mesylate for CML or ALL
* At least 4 weeks since prior investigational anticancer drugs and recovered
* At least 4 weeks since prior palliative treatment for metastatic disease
* No concurrent ketoconazole, warfarin, verapamil, miconazole, or erythromycin
* No other concurrent investigational drugsReferences
Publications (0)
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