Clinical trial · Interventional

3-AP and Cytarabine in Treating Patients With Hematologic Cancer

A Phase I Study of Triapine and Cytarabine in Patients With Hematologic Malignancies

NCT00064090CI-TRIAL-00011423completedPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Drugs used in chemotherapy such as cytarabine use different ways to stop cancer cells from dividing so they stop growing or die. 3-AP may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth and may help cytarabine kill more cancer cells by making them more sensitive to the drug. PURPOSE: Phase I trial to study the effectiveness of combining cytarabine with 3-AP in treating patients who have relapsed or refractory hematologic cancer.

Conditions

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Leukemia	Leukemia	ONTOLOGY_EXACT	0.90
Myelodysplastic/Myeloproliferative Neoplasms	Myelodysplastic/Myeloproliferative Neoplasm	CURATED_BROADER	0.80
Myelodysplastic Syndromes	Myelodysplastic Syndrome	ALIAS	0.90

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
cytarabine	Drug	Cytarabine	ALIAS
triapine	Drug	—	UNRESOLVED

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Diagnosis of 1 of the following hematologic malignancies:

  * Acute myeloid leukemia
  * Acute lymphoblastic leukemia
  * Chronic myelogenous leukemia (CML)
  * CML in blast crisis
  * Chronic lymphocytic leukemia
  * High-risk\* myelodysplastic syndromes, including the following:

    * Refractory anemia with excess blasts (RAEB)
    * RAEB in transformation
    * Chronic myelomonocytic leukemia NOTE: \*High-risk myelodysplasia defined as having an International Performance Scoring System score of at least 1.5, based on adverse cytogenetics, greater than 10% blasts in marrow, and cytopenias in at least 2 lineages
* Relapsed or refractory disease
* Ineligible for higher priority protocols

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-2

Life expectancy

* More than 2 months

Hematopoietic

* See Disease Characteristics

Hepatic

* Bilirubin no greater than 2.0 mg/dL (unless considered due to malignancy)
* ALT or AST no greater than 3 times upper limit of normal
* Chronic hepatitis allowed

Renal

* Creatinine no greater than 2.0 mg/dL (unless considered due to malignancy)

Cardiovascular

* No myocardial infarction within the past 3 months
* No symptomatic coronary artery disease
* No arrhythmias (other than atrial fibrillation or flutter) requiring treatment
* No uncontrolled congestive heart failure

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Concurrent infections under active treatment with and controlled by antibiotics allowed
* No other concurrent life-threatening illness
* No mental deficit or psychiatric history that would preclude giving informed consent or complying with protocol

PRIOR CONCURRENT THERAPY:

Biologic therapy

* At least 1 week since prior growth factors, including the following:

  * Epoetin alfa
  * Filgrastim (G-CSF)
  * Sargramostim (GM-CSF)
  * Interleukin-3
  * Interleukin-11
* No concurrent anticancer immunotherapy

Chemotherapy

* At least 72 hours since prior hydroxyurea
* Recovered from prior chemotherapy
* No other concurrent anticancer chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* At least 2 weeks since prior radiotherapy
* No concurrent anticancer radiotherapy

Surgery

* Not specified

Other

* At least 3 weeks since prior myelosuppressive cytotoxic agents (in the absence of rapidly progressing disease)
* At least 1 week since prior nonmyelosuppressive therapy
* No other concurrent standard or investigational therapy for the malignancy

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Mar 1, 2003
Primary completion: Sep 1, 2004
Completion: Jan 1, 2008
First posted: Jul 9, 2003
Last update posted: Jul 18, 2013
Lead sponsor: Vion Pharmaceuticals INDUSTRY
Keywords: recurrent adult acute lymphoblastic leukemia, recurrent adult acute myeloid leukemia, blastic phase chronic myelogenous leukemia, refractory chronic lymphocytic leukemia, relapsing chronic myelogenous leukemia, chronic myelomonocytic leukemia, refractory anemia with excess blasts in transformation, refractory anemia with excess blasts, previously treated myelodysplastic syndromes, atypical chronic myeloid leukemia, BCR-ABL1 negative, myelodysplastic/myeloproliferative neoplasm, 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)

Data updated 22 days agoSource updated Jul 18, 2013source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
United States	1	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.