- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00045006
Suberoylanilide Hydroxamic Acid in Treating Patients With Advanced Cancer
Phase I Clinical Trial of Oral Suberoylanilide Hydroxamic Acid - SAHA (MSK390) in Patients With Advanced Solid Tumors and Hematologic Malignancies
RATIONALE: Suberoylanilide hydroxamic acid may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase I trial to study the effectiveness of suberoylanilide hydroxamic acid in treating patients who have advanced cancer.
Study Overview
Detailed Description
OBJECTIVES:
- Determine the maximum tolerated dose of suberoylanilide hydroxamic acid in patients with advanced solid tumors or hematologic malignancies.
- Evaluate the pharmacokinetic profile of this drug in these patients.
- Determine the effects of this drug on absorption in the fasting and non-fasting states in these patients.
- Determine any anti-tumor effects of this drug in these patients.
- Correlate clinical outcomes with histone acetylation in circulating mononuclear cells and tumor biopsy samples in patients treated with this drug.
OUTLINE: This is a dose-escalation study. Patients are stratified according to disease (solid tumor vs multiple myeloma or lymphoma vs leukemia or myelodysplastic syndromes).
The initial 15-20 patients (in the solid tumor or multiple myeloma or lymphoma stratum) receive suberoylanilide hydroxamic acid (SAHA) IV over 2 hours on day 1 of week 0 and then orally once or twice daily beginning on day 1 of week 1. All remaining patients receive oral SAHA once or twice daily beginning on day 1 of week 1. Courses repeat every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
In each stratum, cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed monthly for resolution of adverse events.
PROJECTED ACCRUAL: A maximum of 114 patients (42 with solid tumors, 36 with lymphoma or multiple myeloma, and 36 with leukemia or myelodysplastic syndromes) will be accrued for this study within 1 year.
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
New York
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
One of the following diagnoses:
Histologically confirmed advanced primary or metastatic solid tumor, including, but not limited to, the following:
- Androgen-independent prostate cancer
- Breast cancer
- Ovarian cancer
- Head and neck cancer
- Non-small cell lung cancer
- Bladder cancer
- Kidney cancer
Diagnosis of lymphoma, multiple myeloma, leukemia, or myelodysplastic syndromes (MDS), including, but not limited to, the following:
- Intermediate-grade or follicular non-Hodgkin's lymphoma
- Hodgkin's lymphoma
- Patients with lymphoma or multiple myeloma must be ineligible for peripheral blood stem cell transplantation
For patients with solid tumors (except prostate cancer):
- Disease progression based on development of new lesions or an increase in pre-existing lesions
- Biochemical marker increase must not be sole criterion for disease progression
For prostate cancer patients only:
- Disease progression based on rising prostate-specific antigen (PSA) values, transaxial imaging, or radionuclide scans
- Increase in disease-related symptoms must not be sole manifestation of progression
- Patients receiving an antiandrogen as part of first-line hormonal therapy must show disease progression off of the antiandrogen prior to study
Biochemical progression (at least 25% increase over range of values) defined as 1 of the following:
- Rising PSA documented by at least 3 consecutive measurements obtained at least 1 week apart
- Rising PSA documented by at least 2 consecutive measurements obtained more than 1 month apart
PSA at least 4 ng/mL
- Testosterone no greater than 50 ng/mL
- If no prior orchiectomy, must maintain castrate levels of testosterone
- Disease must be refractory to standard therapy or for which no curative therapy exists
- No active CNS or epidural tumors
Hormone receptor status:
- Not specified NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Male or female
Menopausal status
- Not specified
Performance status
- Karnofsky 70-100%
Life expectancy
- Not specified
Hematopoietic
- WBC at least 3,500/mm^3
- Platelet count at least 100,000/mm^3 (patients with solid tumors)
- Platelet count greater than 25,000/mm^3 (patients with hematologic malignancy)
- Absolute neutrophil count at least 500/mm^3 (patients with hematologic malignancy)
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST and ALT no greater than 3 times ULN
- PT no greater than 15 seconds
Renal
- Creatinine no greater than 2.0 mg/dL
Cardiovascular
- No New York Heart Association class III or IV heart disease
Pulmonary
- No severe debilitating pulmonary disease
Other
- No infection requiring IV antibiotics
- No other severe medical problems that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
Chemotherapy
- At least 4 weeks since prior chemotherapy
Endocrine therapy
- See Disease Characteristics
- At least 4 weeks since prior ketoconazole
- At least 2 weeks since prior steroids for patients with lymphoma
- Concurrent gonadotropin-releasing hormone analogs or diethylstilbestrol to maintain castrate levels of testosterone allowed for prostate cancer patients
- No concurrent ketoconazole
Radiotherapy
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy to sole measurable lesion
Surgery
- See Disease Characteristics
- No concurrent surgery
Other
- Recovered from all prior therapy
- At least 4 weeks since prior palliative therapy for solid tumor patients with progressive metastatic disease (if present)
- At least 4 weeks since prior investigational anticancer therapeutic drugs
- At least 2 weeks since prior conventional cytotoxic therapy for patients with leukemia or MDS
- At least 4 weeks since prior investigational therapy for patients with leukemia or MDS
- No other concurrent investigational drugs
- No other concurrent anticancer agents
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage IV renal cell cancer
- recurrent renal cell cancer
- stage IV breast cancer
- stage IIIA breast cancer
- recurrent breast cancer
- stage IIIB breast cancer
- recurrent non-small cell lung cancer
- stage III bladder cancer
- recurrent bladder cancer
- stage IV bladder cancer
- stage III prostate cancer
- stage IV prostate cancer
- recurrent prostate cancer
- 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
- recurrent metastatic squamous neck cancer with occult primary
- stage III squamous cell carcinoma of the lip and oral cavity
- stage III basal cell carcinoma of the lip
- stage III verrucous carcinoma of the oral cavity
- 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 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 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 midline lethal granuloma of the paranasal sinus and nasal cavity
- recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
- recurrent salivary gland cancer
- stage III salivary gland cancer
- stage IV salivary gland cancer
- stage III ovarian epithelial cancer
- stage IV ovarian epithelial cancer
- recurrent ovarian epithelial cancer
- male breast cancer
- stage IIIC breast cancer
- stage III adult diffuse large cell lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV adult diffuse large cell lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse large cell lymphoma
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- secondary acute myeloid leukemia
- recurrent adult acute myeloid leukemia
- recurrent adult Hodgkin lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- relapsing chronic myelogenous leukemia
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage III multiple myeloma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- refractory chronic lymphocytic leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- stage III renal cell cancer
- stage III adult Hodgkin lymphoma
- stage IV adult Hodgkin lymphoma
- stage III cutaneous T-cell non-Hodgkin lymphoma
- stage IV cutaneous T-cell non-Hodgkin lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- stage III adult T-cell leukemia/lymphoma
- stage IV adult T-cell leukemia/lymphoma
- recurrent adult T-cell leukemia/lymphoma
- stage III mycosis fungoides/Sezary syndrome
- stage IV mycosis fungoides/Sezary syndrome
- recurrent mycosis fungoides/Sezary syndrome
- refractory multiple myeloma
- recurrent adult acute lymphoblastic leukemia
- refractory hairy cell leukemia
- prolymphocytic leukemia
- ovarian sarcoma
- borderline ovarian surface epithelial-stromal tumor
- ovarian stromal cancer
- recurrent ovarian germ cell tumor
- stage III ovarian germ cell tumor
- stage IV ovarian germ cell tumor
- myelodysplastic/myeloproliferative neoplasm, unclassifiable
- recurrent inverted papilloma of the paranasal sinus and nasal cavity
- stage III inverted papilloma of the paranasal sinus and nasal cavity
- stage IV inverted papilloma of the paranasal sinus and nasal cavity
- acute undifferentiated leukemia
- stage III oropharyngeal cancer
- stage IV oropharyngeal cancer
- atypical chronic myeloid leukemia, BCR-ABL1 negative
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSKCC-01021
- CDR0000256306 (Registry Identifier: PDQ (Physician Data Query))
- ATON-0101
- NCI-G02-2099
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