Chronic Myeloproliferative DisordersPhase 1/2NCT00003619
Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation or Isotretinoin in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Acute Lymphocytic Leukemia
A Phase 1/2 study testing filgrastim, vitamin E and busulfan in people with Chronic Myeloproliferative Disorders and Leukemia, run by Drexel University College of Medicine at 2 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Chronic Myeloproliferative Disorders, Leukemia, Myelodysplastic Syndromes
- What is being tested?
- filgrastim, vitamin E and busulfan
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Feb 1998to Apr 2004
- Phase
- Phase 1/2
- 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 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically proven poor prognosis acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or recurrent/refractory acute lymphocytic leukemia, including: Myelodysplastic syndrome (MDS) stages B and C Refractory anemia, refractory anemia with ringed sideroblasts, or refractory anemia with excess blasts (between 5% and 20% myeloblasts) MDS with increased erythroblasts or monocytoblasts of no greater than 20% MDS in transformation (between 20% to 30% myeloblasts) or acute nonlymphoblastic leukemia (at least 30% myeloblasts) Chronic myelomonocytic leukemia Poor prognosis refractory or recurrent acute myeloid leukemia after complete response Secondary or therapy related AML or MDS AML blastic crisis of chronic myelogenous leukemia or other myeloproliferative disorders such as polycythemia vera, essential thrombocytopenia, or agnogenic myeloid metaplasia
PATIENT CHARACTERISTICS: Age: 19 to 90 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT or SGPT less than 2.0 times upper limit of normal Renal: Normal serum creatinine Cardiovascular: No congestive heart failure No symptomatic ischemic heart disease Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative No uncontrolled infection No poorly controlled diseases (e.g., diabetes, systemic lupus erythematosus) No history of psychiatric disorders No other malignancies within the past 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix No concurrent severe medical problems No history of allergic reaction to topotecan and its derivatives
PRIOR CONCURRENT THERAPY: Biologic therapy: No other concurrent immunotherapy Chemotherapy: No prior topotecan At least 4 weeks since prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: No other investigational drugs within 30 days of study No other concurrent investigational therapy except for basal cell skin cancer
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical College of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19129
Medical College of Pennsylvania
Philadelphia, Pennsylvania, 19129
About this study
Official title: A Phase I/II Combination Study of Topotecan, Fludarabine, Cytosine Arabinoside and G-CSF (T-FLAG) Induction Therapy in Patients With Poor Prognosis AML, MDS and Relapsed/Refractory ALL Followed by Maintenance of Either PBSC Transplant or 13 Cis-Retinoic Acid
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Isotretinoin may help cancer cells develop into normal white blood cells.
PURPOSE: Phase I/II trial of topotecan, fludarabine, cytarabine, and filgrastim followed by peripheral stem cell transplantation or isotretinoin in treating patients who have acute myeloid leukemia, myelodysplastic syndrome, or recurrent or refractory acute lymphocytic leukemia.
Read the detailed description
OBJECTIVES: I. Determine the safety of topotecan in combination with fludarabine, cytarabine, and filgrastim (FLAG) in patients with poor prognosis acute myeloid leukemia, myelodysplastic syndrome, or recurrent or refractory acute lymphocytic leukemia. II. Determine the maximum tolerated dose of topotecan in the FLAG regimen in these patients. III. Assess the complete remission rates in patients treated with this regimen.
OUTLINE: Patients with complete response proceed to further therapy according to age. 65 and under: Patients receive etoposide by IV continuously for 5 days, cytarabine IV over 2 hours every 12 hours for 4 days, and filgrastim (G-CSF) subcutaneously. Peripheral blood stem cells (PBSC) are then harvested. Patients then receive oral busulfan every 6 hours on days -7 to -4 and etoposide IV over 10 hours on day -3. PBSC are reinfused on day 0. Over 65: Patients receive oral isotretinoin and vitamin E daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every month for 1 year and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 3-4 years.
- Conditions
- Chronic Myeloproliferative Disorders, Leukemia, Myelodysplastic Syndromes, Thrombocytopenia
- Being tested
- filgrastim, vitamin E, busulfan, cytarabine, etoposide
- Keywords
- recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, relapsing chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, polycythemia vera, primary myelofibrosis, refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, chronic myelomonocytic leukemia, secondary acute myeloid leukemia, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, thrombocytopenia
- Medical subject headings
- Myeloproliferative Disorders, Leukemia, Myelodysplastic Syndromes, Thrombocytopenia, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Blast Crisis, Polycythemia Vera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
vitamin EDietary supplement
busulfanDrug
cytarabineDrug
etoposideDrug
isotretinoinDrug
topotecan hydrochlorideDrug
bone marrow ablation with stem cell supportProcedure or surgery
peripheral blood stem cell transplantationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2004 (estimated)
- Study startFeb 1998
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Drexel University College of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Emmanuel C. Besa, MD, Study chair, Drexel University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003619
- Sponsor's protocol ID
- AUH-MCP-70612-01
- Other IDs
- CDR0000066698, AUH-MCP-70612-02P, NCI-V98-1485
- Status last verified
- Feb 2008
- First submitted
- 1 Nov 1999
- Last updated
- 26 Jun 2013
- Results posted
- No
Publications
Besa E, Maiale C, Liman D, et al.: Early data on a new combination chemotherapy using topotecan, fludarabine, ARA-C and G-CSF for aggressive myelodysplastic syndromes in the elderly. [Abstract] Leuk Res 23 (Suppl 1): A-191, S72, 1999.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Combination Study of Topotecan, Fludarabine, Cytosine Arabinoside and G-CSF (T-FLAG) Induction Therapy in Patients With Poor Prognosis AML, MDS and Relapsed/Refractory ALL Followed by Maintenance of Either PBSC Transplant or 13 Cis-Retinoic Acid
- ClinicalTrials.gov ID
- NCT00003619
- Acronym / sponsor ID
- AUH-MCP-70612-01
- Conditions
- Chronic Myeloproliferative Disorders, Leukemia, Myelodysplastic Syndromes, Thrombocytopenia
- Keywords
- recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, relapsing chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, polycythemia vera, primary myelofibrosis, refractory anemia, refractory anemia with ringed sideroblasts
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Drexel University College of MedicineUniversity, hospital or other
- Study start
- Feb 1998
- Study completion
- Apr 2004 (actual)
- First posted
- 27 Apr 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 cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Isotretinoin may help cancer cells develop into normal white blood cells.
PURPOSE: Phase I/II trial of topotecan, fludarabine, cytarabine, and filgrastim followed by peripheral stem cell transplantation or isotretinoin in treating patients who have acute myeloid leukemia, myelodysplastic syndrome, or recurrent or refractory acute lymphocytic leukemia.
Detailed description
OBJECTIVES: I. Determine the safety of topotecan in combination with fludarabine, cytarabine, and filgrastim (FLAG) in patients with poor prognosis acute myeloid leukemia, myelodysplastic syndrome, or recurrent or refractory acute lymphocytic leukemia. II. Determine the maximum tolerated dose of topotecan in the FLAG regimen in these patients. III. Assess the complete remission rates in patients treated with this regimen.
OUTLINE: Patients with complete response proceed to further therapy according to age. 65 and under: Patients receive etoposide by IV continuously for 5 days, cytarabine IV over 2 hours every 12 hours for 4 days, and filgrastim (G-CSF) subcutaneously. Peripheral blood stem cells (PBSC) are then harvested. Patients then receive oral busulfan every 6 hours on days -7 to -4 and etoposide IV over 10 hours on day -3. PBSC are reinfused on day 0. Over 65: Patients receive oral isotretinoin and vitamin E daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every month for 1 year and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 3-4 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 19 to 90 years
- 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 |
|---|---|---|
| filgrastim | Biological | – |
| vitamin E | Dietary supplement | – |
| busulfan | Drug | – |
| cytarabine | Drug | – |
| etoposide | Drug | – |
| fludarabine phosphate | Drug | – |
| isotretinoin | Drug | – |
| topotecan hydrochloride | Drug | – |
| bone marrow ablation with stem cell support | Procedure or surgery | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
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 26 Jun 2013.
- Results publicationBesa E, Maiale C, Liman D, et al.: Early data on a new combination chemotherapy using topotecan, fludarabine, ARA-C and G-CSF for aggressive myelodysplastic syndromes in the elderly. [Abstract] Leuk Res 23 (Suppl 1): A-191, S72, 1999.
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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.
Emmanuel C. Besa, MD study chair
Drexel University College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing filgrastim, vitamin E and busulfan in people with Chronic Myeloproliferative Disorders and Leukemia, run by Drexel University College of Medicine at 2 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 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 combined 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.
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 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?
On the ClinicalTrials.gov record for NCT00003619, which also lists 1 linked publication.
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 26 Jun 2013.