CancerPhase 1NCT00045006
Suberoylanilide Hydroxamic Acid in Treating Patients With Advanced Cancer
A Phase 1 study testing vorinostat in people with Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- vorinostat
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jul 2001to Jul 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer
- Being tested
- vorinostat
- Keywords
- acute undifferentiated leukemia, de novo myelodysplastic syndromes, borderline ovarian surface epithelial-stromal tumor, ovarian sarcoma, ovarian stromal cancer, previously treated myelodysplastic syndromes, prolymphocytic leukemia, recurrent adult Hodgkin lymphoma, recurrent adult T-cell leukemia/lymphoma, recurrent adult acute lymphoblastic leukemia, recurrent adult acute myeloid leukemia, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent bladder cancer, recurrent breast cancer, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma
- Medical subject headings
- Neoplasms, Leukemia, Biphenotypic, Acute, Leukemia, Prolymphocytic, Hodgkin Disease, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vorinostatDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJul 2001
- Primary completionDec 2005
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- William K. Kelly, DO, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00045006
- Sponsor's protocol ID
- MSKCC-01021
- Other IDs
- CDR0000256306, ATON-0101, NCI-G02-2099
- Status last verified
- Oct 2003
- First submitted
- 6 Sep 2002
- Last updated
- 30 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of Oral Suberoylanilide Hydroxamic Acid - SAHA (MSK390) in Patients With Advanced Solid Tumors and Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT00045006
- Acronym / sponsor ID
- MSKCC-01021
- Conditions
- Cancer
- Keywords
- acute undifferentiated leukemia, de novo myelodysplastic syndromes, borderline ovarian surface epithelial-stromal tumor, ovarian sarcoma, ovarian stromal cancer, previously treated myelodysplastic syndromes, prolymphocytic leukemia, recurrent adult Hodgkin lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2001
- Primary completion
- Dec 2005 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vorinostat | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William K. Kelly, DO study chair
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing vorinostat in people with Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2013.