Clofarabine and Temsirolimus in Treating Older Patients With Relapsed or Refractory Acute Myeloid Leukemia - Full Text View

Sponsored by:	Gruppo Italiano Malattie EMatologiche dell'Adulto
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00775593

Purpose

RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving clofarabine together with temsirolimus may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving clofarabine together with temsirolimus works in treating older patients with relapsed or refractory acute myeloid leukemia.

Condition	Intervention	Phase
Leukemia	Drug: clofarabine Drug: temsirolimus	Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: CCI 779 Clofarabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label
Official Title:	An Open Label Phase II Trial of Clofarabine and Temsirolimus in Older Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Complete response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tolerability and safety [ Designated as safety issue: Yes ]
Duration of response [ Designated as safety issue: No ]
Duration of survival [ Designated as safety issue: No ]

Estimated Enrollment:	54
Study Start Date:	December 2008
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

To determine the complete response rate in older patients with relapsed or refractory acute myeloid leukemia when treated with low-dose clofarabine and temsirolimus.

Secondary

To determine the tolerability and safety of this regimen.
To determine the duration of response.
To determine the duration of survival.

OUTLINE: This is a multicenter study.

Induction therapy: Patients receive clofarabine IV over 1 hour on days 1-5 and temsirolimus IV over 30 minutes on days 1, 8, and 15. Treatment continues for 1-2 courses in the absence of disease progression or unacceptable toxicity.
Maintenance therapy: Patients achieving morphologic complete remission (CR) or CR with incomplete blood count recovery receive temsirolimus IV over 30 minutes on days 1 and 8 of each month. Treatment continues for 12 months in the absence of disease progression or unacceptable toxicity.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Cytologically confirmed acute myeloid leukemia (AML) meeting the following criteria:
- At least 20% of blasts in the bone marrow
- AML in first relapse OR refractory to no more than one prior combination chemotherapy induction regimen
No acute promyelocytic leukemia
No blast transformation of chronic myeloid leukemia or other myeloproliferative disorders
No active CNS leukemia

PATIENT CHARACTERISTICS:

WHO performance status 0-2
Life expectancy ≥ 4 weeks
Serum total bilirubin ≤ 1.5 times upper limit of normal (ULN)*
AST and ALT ≤ 2.5 times ULN*
Serum creatinine ≤ 1.0 mg/dL* OR estimated glomerular filtration rate > 60 mL/min
No active uncontrolled systemic infection
No concurrent active malignancy
No HIV positivity
No severe concurrent medical condition or psychiatric disorder that would preclude study participation NOTE: *Unless due to organ leukemic involvement

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
More than 2 weeks since prior myelosuppressive chemotherapy
At least 48 hours since prior hydroxyurea
No prior clofarabine or temsirolimus
No prior allogeneic stem cell transplantation
No investigational drug within the past 30 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00775593

Locations

Italy
Ospedale Sant' Eugenio	Recruiting
Rome, Italy, 00144
Contact: Sergio Amadori, MD 39-06-591-4745 mc7673@mclink.it

Sponsors and Collaborators

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

Principal Investigator:

Sergio Amadori, MD

Ospedale Sant' Eugenio

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000617326, GIMEMA-AML-1107, EUDRACT-2007-005374-31, EU-20886, WYETH-GIMEMA-AML-1107
Study First Received:	October 17, 2008
Last Updated:	October 17, 2008
ClinicalTrials.gov Identifier:	NCT00775593
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

recurrent adult acute myeloid leukemia
adult acute basophilic leukemia
adult acute eosinophilic leukemia
adult erythroleukemia (M6a)
adult pure erythroid leukemia (M6b)
adult acute megakaryoblastic leukemia (M7)
adult acute minimally differentiated myeloid leukemia (M0)
adult acute monoblastic leukemia (M5a)

adult acute monocytic leukemia (M5b)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myelomonocytic leukemia (M4)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
adult acute myeloid leukemia with inv(16)(p13;q22)

Study placed in the following topic categories:

Clofarabine
Leukemia, Monocytic, Acute
Acute myelogenous leukemia
Acute myelomonocytic leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Di Guglielmo's syndrome
Recurrence

Leukemia, Myelomonocytic, Acute
Leukemia
Leukemia, Erythroblastic, Acute
Acute erythroblastic leukemia
Acute myeloid leukemia, adult
Congenital Abnormalities
Acute monoblastic leukemia
Acute myelocytic leukemia

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009