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AzTrials

LeukemiaPhase 2NCT00053287

Fludarabine/Carboplatin/Topotecan w/Thalidomide for Relapsed/Refractory AML, CML and MDS

A Phase 2 study testing carboplatin, fludarabine phosphate and thalidomide in people with Leukemia and Myelodysplastic Syndromes, run by Case Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor. Combining chemotherapy with thalidomide may kill more cancer cells. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
carboplatin, fludarabine phosphate and thalidomide
How many people
42 participants
Where
1 siteUnited States
Study dates
Sep 2002to Mar 2007
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:

  • Diagnosis of 1 of the following:
  • Acute myeloid leukemia meeting 1 of the following criteria:
  • Previously untreated and not a candidate for anthracycline-based chemotherapy
  • In first or second relapse or refractory
  • Secondary to chemotherapy or an antecedent hematologic disorder and treated with no more than 1 prior intensive induction regimen
  • Chronic myelogenous leukemia in blast crisis at diagnosis or after prior imatinib mesylate
  • Myelodysplastic syndromes (MDS)
  • Refractory anemia with excess blasts (RAEB) or RAEB in transformation
  • Must meet at least 1 of the following criteria:
  • Absolute neutrophil count no greater than 500/mm^3
  • Platelet or red cell transfusion-dependent after no more than 1 prior intensive induction chemotherapy
  • Acute promyelocytic leukemia
  • t(15, 17)
  • Failed prior treatment with tretinoin and arsenic
  • Relapsed disease at least 3 months after prior autologous stem cell transplantation
  • No active CNS leukemia

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-3

Life expectancy

  • At least 8 weeks

Hematopoietic

  • See Disease Characteristics

Hepatic

  • Bilirubin no greater than 2.0 mg/dL
  • AST and ALT less than 3 times upper limit of normal

Renal

  • Creatinine clearance at least 50 mL/min

Cardiovascular

  • Ejection fraction at least 40%
  • No poorly controlled cardiac disease

Pulmonary

  • No poorly controlled pulmonary disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile female patients must use 1 highly effective and 1 additional method of contraception for 4 weeks before, during, and for at least 4 weeks after study
  • Male patients must use effective contraception during and for 4 weeks after study
  • Willing and able to comply with the System for Thalidomide Education and Prescribing Safety (STEPS) program
  • HIV negative
  • No poorly controlled infection
  • No other active malignancy
  • No severe peripheral neuropathy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • Prior thalidomide allowed for MDS
  • At least 5 days since prior hematopoietic growth factors
  • At least 2 weeks since prior biologic therapy
  • No prior allogeneic bone marrow transplantation

Chemotherapy

  • See Disease Characteristics
  • At least 24 hours since prior hydroxyurea

Endocrine therapy

  • At least 24 hours since prior corticosteroids

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • At least 2 weeks since prior cytotoxic anticancer therapy
  • Prior amifostine allowed for MDS

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106-5065

Other trials in United States

About this study

Official title: Phase II Study of Fludarabine, Carboplatin, and Topotecan With Thalidomide for Patients With Relapsed/Refractory or High Risk Acute Myelogenous Leukemia, Chronic Myeloid Leukemia and Advanced Myelodysplastic Syndromes

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor. Combining chemotherapy with thalidomide may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining fludarabine, carboplatin, and topotecan with thalidomide in treating patients who have relapsed or refractory acute myeloid leukemia, chronic myelogenous leukemia, or advanced myelodysplastic syndromes.

Read the detailed description

OBJECTIVES:

  • Determine the response rate of patients with relapsed/refractory or high-risk acute myeloid leukemia, chronic myelogenous leukemia, or advanced myelodysplastic syndromes treated with fludarabine, carboplatin, topotecan, and thalidomide.
  • Determine the non-hematologic toxicity profile and time to hematopoietic recovery in patients treated with this regimen.
  • Determine the effects of this regimen on changes in biologic parameters that may predict response in these patients.
  • Correlate bone marrow microvascular density before and after treatment with response in these patients.
  • Determine the prognostic value of pretreatment plasma and serum levels of vascular endothelial growth factor (VEGF) and/or the modulation of serum levels of VEGF during treatment in predicting response in these patients.

OUTLINE: Patients are stratified according to diagnosis (previously untreated acute leukemia vs other).

Patients receive fludarabine IV over 5-10 minutes and carboplatin IV over 24 hours on days 1-5 followed by topotecan IV continuously over 72 hours. Patients receive oral thalidomide daily beginning within days 1-3 and continuing in the absence of disease progression or unacceptable toxicity.

Patients with residual disease on day 16-18 may receive a second course of chemotherapy as above. Patients who achieve remission may receive a third course of chemotherapy as above as consolidation beginning 4-8 weeks after completion of prior chemotherapy.

Patients are followed monthly for 6 months.

PROJECTED ACCRUAL: A total of 40 patients (20 per stratum) will be accrued for this study.

Being tested
carboplatin, fludarabine phosphate, thalidomide, topotecan hydrochloride
Keywords
adult acute promyelocytic leukemia (M3), refractory anemia with excess blasts in transformation, refractory anemia with excess blasts, de novo myelodysplastic syndromes, recurrent adult acute myeloid leukemia, secondary acute myeloid leukemia, untreated adult acute myeloid leukemia, blastic phase chronic myelogenous leukemia, relapsing chronic myelogenous leukemia, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, atypical chronic myeloid leukemia, myelodysplastic/myeloproliferative disease, unclassifiable, adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with t(15;17)(q22;q12)
Medical subject headings
Leukemia, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Leukemia, Promyelocytic, Acute, Anemia, Refractory, with Excess of Blasts, Leukemia, Myeloid, Acute, Blast Crisis, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • carboplatinDrug

    Carboplatin IV over 24 hours on days 1-5

  • fludarabine phosphateDrug

    Fludarabine IV over 5-10 minutes on days 1-5.

  • thalidomideDrug

    Oral thalidomide daily beginning within days 1-3 and continuing in the absence of disease progression or unacceptable toxicity.

  • topotecan hydrochlorideDrug

    Topotecan IV continuously over 72 hours.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete response rate

    Measured: 6 weeks after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2003 (estimated)
  2. Study startSep 2002
  3. Primary completionJan 2007
  4. Study completionMar 2007

Resources

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00053287
Sponsor's protocol ID
CWRU1902
Other IDs
P30CA043703, CASE-CWRU-1902, CELGENE-CWRU-1902, CASE-1902
Status last verified
Jun 2010
First submitted
27 Jan 2003
Last updated
10 Jun 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carboplatin, fludarabine phosphate and thalidomide in people with Leukemia and Myelodysplastic Syndromes, run by Case Comprehensive 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 10 Jun 2010. 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 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.

What does the primary outcome measure?

Complete response rate (time frame: 6 weeks after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00053287.

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 10 Jun 2010.

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