Chemotherapy in Treating Patients With Refractory Advanced Solid Tumors or Hematologic Cancer

NCT00004065 | Completed Phase 1

• 4 other identifiers: 99-037CDR0000067267NCI-T99-0035UCLA-0206019
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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

Bladder Cancer; Breast Cancer; Colorectal Cancer; Gastric Cancer; Head and Neck Cancer; Kidney Cancer; Leukemia; Lung Cancer; Melanoma (Skin); Ovarian Cancer; Prostate Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

stage III colon cancer; stage IV colon cancer; stage IV breast cancer; stage IIIA breast cancer; recurrent breast cancer; stage III gastric cancer; stage IV gastric cancer; recurrent gastric cancer; stage IIIB breast cancer; stage IIIC breast cancer; recurrent non-small cell lung cancer; recurrent colon cancer; stage III renal cell cancer; stage IV renal cell cancer; recurrent renal cell cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; recurrent ovarian epithelial cancer; recurrent adult acute lymphoblastic leukemia; relapsing chronic myelogenous leukemia; stage III bladder cancer; recurrent bladder cancer; stage IV bladder cancer; stage III prostate cancer; stage IV prostate cancer; recurrent prostate cancer; stage III melanoma; stage IV melanoma; recurrent melanoma; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; unspecified adult solid tumor, protocol specific; chronic phase chronic myelogenous leukemia; accelerated phase chronic myelogenous leukemia; blastic phase chronic myelogenous leukemia; untreated metastatic squamous neck cancer with occult primary; recurrent metastatic squamous neck cancer with occult primary; ovarian stromal cancer; stage III ovarian germ cell tumor; stage IV ovarian germ cell tumor; recurrent ovarian germ cell tumor; stage III squamous cell carcinoma of the lip and oral cavity; stage III basal cell carcinoma of the lip; stage III mucoepidermoid carcinoma of the oral cavity; stage III adenoid cystic carcinoma of the oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; stage IV basal cell carcinoma of the lip; stage IV verrucous carcinoma of the oral cavity; stage IV mucoepidermoid carcinoma of the oral cavity; stage IV adenoid cystic carcinoma of the oral cavity; recurrent squamous cell carcinoma of the lip and oral cavity; recurrent basal cell carcinoma of the lip; recurrent verrucous carcinoma of the oral cavity; recurrent mucoepidermoid carcinoma of the oral cavity; recurrent adenoid cystic carcinoma of the oral cavity; stage III squamous cell carcinoma of the oropharynx; stage III lymphoepithelioma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; stage IV lymphoepithelioma of the oropharynx; recurrent squamous cell carcinoma of the oropharynx; recurrent lymphoepithelioma of the oropharynx; stage III squamous cell carcinoma of the nasopharynx; stage III lymphoepithelioma of the nasopharynx; stage IV squamous cell carcinoma of the nasopharynx; stage IV lymphoepithelioma of the nasopharynx; recurrent squamous cell carcinoma of the nasopharynx; recurrent lymphoepithelioma of the nasopharynx; stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage III verrucous carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; stage IV verrucous carcinoma of the larynx; recurrent squamous cell carcinoma of the larynx; recurrent verrucous carcinoma of the larynx; stage III squamous cell carcinoma of the paranasal sinus and nasal cavity; stage III inverted papilloma of the paranasal sinus and nasal cavity; stage III midline lethal granuloma of the paranasal sinus and nasal cavity; stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IV inverted papilloma of the paranasal sinus and nasal cavity; stage IV midline lethal granuloma of the paranasal sinus and nasal cavity; stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity; recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity; recurrent inverted papilloma of the paranasal sinus and nasal cavity; recurrent midline lethal granuloma of the paranasal sinus and nasal cavity; recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity; borderline ovarian surface epithelial-stromal tumor; ovarian sarcoma; stage III verrucous carcinoma of the oral cavity; recurrent salivary gland cancer; stage IV salivary gland cancer; stage III salivary gland cancer

Interventions

tanespimycin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 drugs

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms; Head and Neck Neoplasms; Kidney Neoplasms; Leukemia; Lung Neoplasms; Melanoma; Ovarian Neoplasms; Prostatic Neoplasms; Colonic Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Carcinoma, Ovarian Epithelial; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Chronic-Phase; Leukemia, Myeloid, Accelerated Phase; Blast Crisis; Squamous Cell Carcinoma of Head and Neck; Esthesioneuroblastoma, Olfactory; Salivary Gland Neoplasms

Interventions

tanespimycin

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Stomach Diseases; Kidney Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes; Carcinoma, Squamous Cell; Neuroblastoma; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Olfactory Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases

Study Officials

• Howard I. Scher, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 10, 1999
• First Posted: January 27, 2003
• Study Start: July 1, 1999
• Primary Completion: March 1, 2005
• Study Completion: March 1, 2005
• Last Updated: June 24, 2013

Record last verified: 2013-06

Locations

US (2)