Chronic Myeloproliferative DisordersPhase 1NCT00002980
Decitabine in Treating Patients With Melanoma or Other Advanced Cancer
A Phase 1 study testing decitabine in people with Chronic Myeloproliferative Disorders and Leukemia, run by California Cancer Consortium at 4 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of decitabine in treating patients with stage III or stage IV melanoma or other advanced cancer that has not responded to previous therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma
- What is being tested?
- decitabine
- How many people
- Not given
- Where
- 4 sitesUnited States
- Study dates
- May 1997to not given
- 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: Stage III (nonresectable) and IV melanoma, or any other advanced metastatic malignancy for which all standard therapy has failed Must have at least two cutaneous, mucosal or lymph nodal lesions that can be biopsied or one lesion large enough to be biopsied twice
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Hemoglobin at least 9.0 g/dL Platelet count at least 100,000/mm3 WBC at least 3500/mm3 Absolute granulocyte count at least 1500/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT and SGPT less than 2.5 times normal Renal: Creatinine no greater than 1.8 mg/dL Other: Not pregnant Not HIV or hepatitis BsAg positive No major systemic infections No coagulation disorders No major illness of cardiovascular or respiratory systems No symptomatic CNS disease or evidence of cerebral edema
PRIOR CONCURRENT THERAPY: No therapy for cancer within the past month
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Beckman Research Institute, City of Hope
Duarte, California, 91010
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033-0800
Los Angeles County-University of Southern California Medical Center
Los Angeles, California, 90033
University of California Davis Cancer Center
Sacramento, California, 95817
About this study
Official title: A Phase I Study of the Biologic and Clinical Effects of 5-AZA-2'Deoxycytidine (DAC) in Patients With Advanced Malignancies
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of decitabine in treating patients with stage III or stage IV melanoma or other advanced cancer that has not responded to previous therapy.
Read the detailed description
OBJECTIVES: I. Identify dosage level(s) of decitabine (DAC) that show biologic activity and acceptable side effects. II. Describe the side effects and toxicity of DAC at the doses studied. III. Determine the steady state DAC serum levels at the doses studied. IV. Document any clinical responses to DAC.
OUTLINE: A dose escalation schedule for the administration of decitabine (DAC) is being used to determine the MTD and biologically active dose. Patients are given two 12 hour continuous infusions per day, for 3 days at each dose level. A minimum of 3 patients are enrolled at each dose level until dose limiting toxicity (DLT) or biologic activity is observed. If DLT or biologic activity is observed at a particular dose level, an additional 3 patients are enrolled, for a total of 6. If 2 or more patients experience DLT, dose escalation is ceased.
PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study.
- Conditions
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Precancerous Condition
- Being tested
- decitabine
- Keywords
- stage IV adult Hodgkin lymphoma, monoclonal gammopathy of undetermined significance, recurrent adult Hodgkin lymphoma, isolated plasmacytoma of bone, extramedullary plasmacytoma, refractory multiple myeloma, Waldenström macroglobulinemia, stage IV chronic lymphocytic leukemia, recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, relapsing chronic myelogenous leukemia, refractory chronic lymphocytic leukemia, unspecified adult solid tumor, protocol specific, chronic phase chronic myelogenous leukemia, accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, untreated adult acute lymphoblastic leukemia, untreated adult acute myeloid leukemia, adult acute myeloid leukemia in remission, adult acute lymphoblastic leukemia in remission
- Medical subject headings
- Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Precancerous Conditions, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decitabineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2004 (estimated)
- Study startMay 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloproliferative DisordersStudies of the same condition, open and under way.
- 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
- California Cancer Consortium
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Jeffrey S. Weber, MD, PhD, Study chair, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002980
- Sponsor's protocol ID
- CDR0000065502
- Other IDs
- LAC-USC-0C963, NCI-T95-0070
- Status last verified
- May 2007
- First submitted
- 1 Nov 1999
- Last updated
- 15 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Biologic and Clinical Effects of 5-AZA-2'Deoxycytidine (DAC) in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT00002980
- Acronym / sponsor ID
- CDR0000065502
- Conditions
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Precancerous Condition
- Keywords
- stage IV adult Hodgkin lymphoma, monoclonal gammopathy of undetermined significance, recurrent adult Hodgkin lymphoma, isolated plasmacytoma of bone, extramedullary plasmacytoma, refractory multiple myeloma, Waldenström macroglobulinemia, stage IV chronic lymphocytic leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- California Cancer ConsortiumResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 1997
- First posted
- 3 Sep 2004 (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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of decitabine in treating patients with stage III or stage IV melanoma or other advanced cancer that has not responded to previous therapy.
Detailed description
OBJECTIVES: I. Identify dosage level(s) of decitabine (DAC) that show biologic activity and acceptable side effects. II. Describe the side effects and toxicity of DAC at the doses studied. III. Determine the steady state DAC serum levels at the doses studied. IV. Document any clinical responses to DAC.
OUTLINE: A dose escalation schedule for the administration of decitabine (DAC) is being used to determine the MTD and biologically active dose. Patients are given two 12 hour continuous infusions per day, for 3 days at each dose level. A minimum of 3 patients are enrolled at each dose level until dose limiting toxicity (DLT) or biologic activity is observed. If DLT or biologic activity is observed at a particular dose level, an additional 3 patients are enrolled, for a total of 6. If 2 or more patients experience DLT, dose escalation is ceased.
PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study.
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 |
|---|---|---|
| decitabine | 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 15 Feb 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.
Jeffrey S. Weber, MD, PhD study chair
University of Southern California
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing decitabine in people with Chronic Myeloproliferative Disorders and Leukemia, run by California Cancer Consortium at 4 sites 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 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 15 Feb 2013.