Paclitaxel in Treating Patients With Refractory or Recurrent Acute Leukemia or Chronic Myelogenous Leukemia

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

Switzerland

Study Type

Interventional

Intervention

paclitaxel

About this trial

This is an interventional treatment trial for Leukemia focused on measuring recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, blastic phase chronic myelogenous leukemia, untreated adult acute lymphoblastic leukemia, untreated adult acute myeloid leukemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed acute myelogenous leukemia (AML), acute lymphoblastic leukemia (ALL) of B-cell or T-cell type, or blast crisis of chronic myelogenous leukemia (CML) Must fulfill one of the following criteria: - Newly diagnosed, previously untreated AML or ALL in elderly patients (65 75) - First or subsequent relapse of AML or ALL after standard chemotherapy, autologous or allogeneic bone marrow transplantation, or high-dose treatment with peripheral blood stem cell support - AML or ALL that is refractory to standard chemotherapy (no complete remission achieved after 2 courses of conventional induction chemotherapy) - CML in blast crisis of any subtype (i.e., myelogenous or lymphoblastic) with or without previously known chronic phase No leukemic involvement of the central nervous system PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: WHO 0-3 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 1.25 times upper limit of normal (ULN) Renal: Creatinine less than 1.25 times ULN Cardiovascular: No history of atrial or ventricular arrhythmias No history of congestive heart failure, even if medically controlled No history of documented myocardial infarction Neurologic: No motor or sensory neuropathy grade 2 or more No dementia or significantly altered mental status Other: HIV negative No active infection or other serious underlying medical condition No prior allergic reaction to a drug containing Cremophor EL No complete bowel obstruction Not pregnant or nursing Adequate contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: No required concurrent cytoreductive treatment in addition to paclitaxel No concurrent growth factors or cytokine No concurrent immunotherapeutic drugs Chemotherapy: No prior paclitaxel or related compounds for a malignancy other that leukemia No required concurrent cytoreductive treatment in addition to paclitaxel Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00003230

First Posted

November 1, 1999

Last Updated

May 14, 2012

Sponsor

Swiss Group for Clinical Cancer Research

1. Study Identification

Unique Protocol Identification Number

NCT00003230

Brief Title

Paclitaxel in Treating Patients With Refractory or Recurrent Acute Leukemia or Chronic Myelogenous Leukemia

Official Title

Paclitaxol (Taxol) for Refractory or Relapsed Acute Leukemia in Elderly Patients, and Blast Crisis of Chronic Myelogenous Leukemia: A Multicenter Phase I/II Study

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

January 1998 (undefined)

Primary Completion Date

July 2000 (Actual)

Study Completion Date

July 2000 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Swiss Group for Clinical Cancer Research

4. Oversight

5. Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of paclitaxel in treating patients with refractory or recurrent acute leukemia or chronic myelogenous leukemia.

Detailed Description

OBJECTIVES: I. Determine the maximum tolerated dose of paclitaxel given as a 96-hour infusion in patients with acute leukemia refractory to or recurrent after standard chemotherapy, in patients with blast crisis of chronic myelogenous leukemia, or in elderly patients (65-75) with newly diagnosed acute leukemia. II. Determine the rate of complete and partial remissions to paclitaxel treatment in these patients. III. Assess the toxic effects of paclitaxel given as a 96-hour infusion in these patients. IV. Determine the duration of remission after paclitaxel treatment in these patient populations. OUTLINE: This is a dose escalation, multicenter study. Patients receive paclitaxel as a 96-hour continuous infusion. Patients may receive a second course of treatment after 4 weeks in the absence of unacceptable toxicity irrespective of the treatment results after 1 course. Cohorts of 3 patients are treated at escalating doses of paclitaxel in the absence of dose limiting toxicity (DLT). If 1 out of 3 patients develops DLT, then 3 additional patients are treated at the same dose level. If DLT occurs in more than 1 out of 3-6 patients, dose escalation stops and this is considered the maximum tolerated dose (MTD). Once the MTD has been defined, the next patients are entered at the dose level preceding the MTD for the phase II portion of the study. Patient are followed at 2 weeks after completion of study and then every 3-6 months thereafter. PROJECTED ACCRUAL: There will be a total of 33 patients accrued (22 patients in the first stage and 11 in the second stage) in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukemia

Keywords

recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, blastic phase chronic myelogenous leukemia, untreated adult acute lymphoblastic leukemia, untreated adult acute myeloid leukemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Enrollment

33 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

paclitaxel

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed acute myelogenous leukemia (AML), acute lymphoblastic leukemia (ALL) of B-cell or T-cell type, or blast crisis of chronic myelogenous leukemia (CML) Must fulfill one of the following criteria: - Newly diagnosed, previously untreated AML or ALL in elderly patients (65 75) - First or subsequent relapse of AML or ALL after standard chemotherapy, autologous or allogeneic bone marrow transplantation, or high-dose treatment with peripheral blood stem cell support - AML or ALL that is refractory to standard chemotherapy (no complete remission achieved after 2 courses of conventional induction chemotherapy) - CML in blast crisis of any subtype (i.e., myelogenous or lymphoblastic) with or without previously known chronic phase No leukemic involvement of the central nervous system PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: WHO 0-3 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 1.25 times upper limit of normal (ULN) Renal: Creatinine less than 1.25 times ULN Cardiovascular: No history of atrial or ventricular arrhythmias No history of congestive heart failure, even if medically controlled No history of documented myocardial infarction Neurologic: No motor or sensory neuropathy grade 2 or more No dementia or significantly altered mental status Other: HIV negative No active infection or other serious underlying medical condition No prior allergic reaction to a drug containing Cremophor EL No complete bowel obstruction Not pregnant or nursing Adequate contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: No required concurrent cytoreductive treatment in addition to paclitaxel No concurrent growth factors or cytokine No concurrent immunotherapeutic drugs Chemotherapy: No prior paclitaxel or related compounds for a malignancy other that leukemia No required concurrent cytoreductive treatment in addition to paclitaxel Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Albert von Rohr, MD

Organizational Affiliation

Klinik Hirslanden, Zurich

Official's Role

Study Chair

Facility Information:

Facility Name

Kantonspital Aarau

City

Aarau

ZIP/Postal Code

5001

Country

Switzerland

Facility Name

Office of Walter Weber-Stadelman

City

Basel

ZIP/Postal Code

CH 4051

Country

Switzerland

Facility Name

University Hospital

City

Basel

ZIP/Postal Code

CH-4031

Country

Switzerland

Facility Name

Inselspital, Bern

City

Bern

ZIP/Postal Code

CH-3010

Country

Switzerland

Facility Name

Hopital Cantonal Universitaire de Geneva

City

Geneva

ZIP/Postal Code

CH-1211

Country

Switzerland

Facility Name

Istituto Oncologico della Svizzera Italiana

City

Lugano

ZIP/Postal Code

CH-6900

Country

Switzerland

Facility Name

Burgerspital, Solothurn

City

Solothurn

ZIP/Postal Code

4500

Country

Switzerland

Facility Name

City Hospital Triemli

City

Zurich

ZIP/Postal Code

8063

Country

Switzerland

Facility Name

Klinik Hirslanden

City

Zurich

ZIP/Postal Code

CH-8008

Country

Switzerland

Leukemia

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial