NCT00045513

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of combining UCN-01 with fludarabine in treating patients who have relapsed or refractory chronic lymphocytic leukemia or lymphocytic lymphoma.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2002

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
Last Updated

July 23, 2015

Status Verified

July 1, 2015

Enrollment Period

1.5 years

First QC Date

September 6, 2002

Last Update Submit

July 22, 2015

Conditions

LeukemiaLymphoma

Keywords

refractory chronic lymphocytic leukemiarecurrent small lymphocytic lymphoma

Interventions

7-hydroxystaurosporineDRUG
fludarabine phosphateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed chronic lymphocytic leukemia (CLL) or B-cell small lymphocytic lymphoma (SLL) * CLL is defined as: * Persistent lymphocytosis greater than 5,000/mm\^3 * CD19/CD5/CD23 positive * Kappa or lambda light chain restriction * Refractory to or disease progression after 1 or 2 prior treatment regimens * Retreatment with oral chlorambucil is allowed and considered a second regimen * At least one of the chlorambucil treatments must be for 3 months or longer * At least 4 courses of cyclophosphamide, vincristine, and prednisone with or without doxorubicin allowed * Patients may have received prior fludarabine as first- or second-line therapy if there is evidence of at least partial response and time to progression after initial fludarabine therapy was at least 12 months * No CNS involvement by lymphoma PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * More than 3 months Hematopoietic * See Disease Characteristics * Absolute neutrophil count at least 1,000/mm\^3 * Platelet count at least 100,000/mm\^3 * No autoimmune hemolytic anemia or thrombocytopenia secondary to CLL or SLL requiring ongoing therapy with prednisone or other immunosuppressive agents Hepatic * Bilirubin normal * AST and ALT no greater than 2.5 times upper limit of normal Renal * Creatinine normal OR * Creatinine clearance at least 60 mL/min Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Pulmonary * DLCO greater than 60% predicted * FEV\_1 greater than 70% predicted * No significant underlying pulmonary disease Other * No other malignancy within the past 5 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix * No insulin-dependent diabetes mellitus * No other uncontrolled concurrent illness * No ongoing or active infection * No pre-existing peripheral neuropathy grade 2 or greater * No psychiatric illness or social situation that would preclude study compliance * No prior allergic reactions to compounds of similar chemical or biological composition to UCN-01 or other agents in this study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * At least 4 weeks since prior chemotherapy and recovered Endocrine therapy * See Hematopoietic Radiotherapy * No prior mediastinal radiation * At least 4 weeks since prior radiotherapy and recovered Surgery * Not specified Other * No other concurrent investigational agents * No concurrent combination antiretroviral therapy for HIV-positive patients

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 465, Canada

Location

Princess Margaret Hospital at University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

LeukemiaLymphomaLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

7-hydroxystaurosporinefludarabine phosphate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael R. Crump, MD, FRCPC

    Princess Margaret Hospital, Canada

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2002

First Posted

January 27, 2003

Study Start

June 1, 2002

Primary Completion

December 1, 2003

Last Updated

July 23, 2015

Record last verified: 2015-07

Locations

CA(3)