LeukemiaPhase 2NCT00003561
Interferon Alfa Plus Sargramostim in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
A Phase 2 study testing recombinant interferon alfa and sargramostim in people with Leukemia, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- recombinant interferon alfa and sargramostim
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1998to Aug 2010
- Phase
- Phase 2
- 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: Cytogenetically or molecularly proven chronic phase chronic myeloid leukemia (CML) that is Philadelphia chromosome positive OR Philadelphia chromosome negative with evidence of the BCR-ABL rearrangement or evidence of the P120 protein On interferon alfa therapy less than 6 months In complete hematologic response, defined as: WBC less than 10,000/mm3 Platelet count less than 450,000/mm3 Less than 5% circulating blasts No signs and symptoms of disease, including progressive splenomegaly
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception No history of intolerance to sargramostim (GM-CSF) Must be able to perform self injection
PRIOR CONCURRENT THERAPY: Biologic therapy: Prior interferon alfa required Chemotherapy: Prior hydroxyurea and cytarabine allowed Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No other concurrent myelosuppressive drug therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231-2410
About this study
Official title: Granulocyte-Macrophage Colony Stimulating Factor (Rhu-GM-CSF) With Interferon-Alpha (IFN-alpha) for Chronic Myeloid Leukemia
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of therapy. Combining sargramostim with interferon alfa may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of sargramostim in treating patients who are receiving interferon alfa for chronic phase chronic myelogenous leukemia that is in remission.
Read the detailed description
OBJECTIVES: I. Estimate the rate of major cytogenetic responses to sargramostim (GM-CSF) and interferon alfa in patients with newly diagnosed chronic phase chronic myeloid leukemia. II. Estimate the dosing, schedule, and toxic effects of GM-CSF plus interferon alfa in these patients.
OUTLINE: All patients are in hematologic remission on subcutaneous interferon alfa upon entering the study. Once a complete hematologic response is achieved and the interferon alfa dose has been stable for 14 days, patients receive subcutaneous sargramostim (GM-CSF) daily for 6 months. Patients are followed at 3, 6, 9, and 12 months.
PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study.
- Conditions
- Leukemia
- Being tested
- recombinant interferon alfa, sargramostim
- Keywords
- chronic phase chronic myelogenous leukemia, Philadelphia chromosome positive chronic myelogenous leukemia, Philadelphia chromosome negative chronic myelogenous leukemia
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Chronic-Phase, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant interferon alfaBiological
sargramostimBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2004 (estimated)
- Study startFeb 1998
- Primary completionOct 2001
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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 2
- Primary purpose
- Treatment
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Richard J. Jones, MD, Study chair, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003561
- Sponsor's protocol ID
- CDR0000066625
- Other IDs
- P30CA006973, JHOC-98011606, JHOC-9806, NCI-V98-1468
- Status last verified
- Apr 2011
- First submitted
- 1 Nov 1999
- Last updated
- 20 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Granulocyte-Macrophage Colony Stimulating Factor (Rhu-GM-CSF) With Interferon-Alpha (IFN-alpha) for Chronic Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT00003561
- Acronym / sponsor ID
- CDR0000066625
- Conditions
- Leukemia
- Keywords
- chronic phase chronic myelogenous leukemia, Philadelphia chromosome positive chronic myelogenous leukemia, Philadelphia chromosome negative chronic myelogenous leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 1998
- Primary completion
- Oct 2001 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 22 Mar 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: Interferon alfa may interfere with the growth of cancer cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of therapy. Combining sargramostim with interferon alfa may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of sargramostim in treating patients who are receiving interferon alfa for chronic phase chronic myelogenous leukemia that is in remission.
Detailed description
OBJECTIVES: I. Estimate the rate of major cytogenetic responses to sargramostim (GM-CSF) and interferon alfa in patients with newly diagnosed chronic phase chronic myeloid leukemia. II. Estimate the dosing, schedule, and toxic effects of GM-CSF plus interferon alfa in these patients.
OUTLINE: All patients are in hematologic remission on subcutaneous interferon alfa upon entering the study. Once a complete hematologic response is achieved and the interferon alfa dose has been stable for 14 days, patients receive subcutaneous sargramostim (GM-CSF) daily for 6 months. Patients are followed at 3, 6, 9, and 12 months.
PROJECTED ACCRUAL: Approximately 48 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 |
|---|---|---|
| recombinant interferon alfa | Biological | – |
| sargramostim | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2011.
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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.
Richard J. Jones, MD study chair
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing recombinant interferon alfa and sargramostim in people with Leukemia, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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: stopped early, as of the sponsor's last update on 20 Jul 2011. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early. Results are not available in the source record.
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 20 Jul 2011.