Status:
COMPLETED
SL-11047 in Treating Patients With Relapsed or Refractory Lymphoma
Lead Sponsor:
Progen Pharmaceuticals
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as SL-11047, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase ...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose (MTD) of SL-11047 in patients with relapsed or refractory lymphoma. * Describe and quantify the toxicity of SL-11047 administered to patien...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically\* confirmed Hodgkin's or non-Hodgkin's lymphoma (NHL) of any histology
- The following NHL types are eligible:
- Diffuse large B-cell lymphoma
- Follicular lymphoma
- Mantle Cell lymphoma
- Marginal zone lymphoma (including lymphoma of mucosa-associated tissue \[MALT\])
- Anaplastic large cell lymphoma
- Peripheral T-cell lymphoma
- Cutaneous T-cell lymphoma
- T/NK cell lymphoma
- Angioimmunoblastic lymphadenopathy-type T-cell lymphoma
- Burkitt's lymphoma NOTE: \* If histologic confirmation was made at initial diagnosis, confirmation of relapsed or refractory disease can be made by repeat histologic evaluation OR by evidence of regrowth at a site of disease that was previously histologically confirmed
- Relapsed after or refractory to ≥ 2 prior therapeutic regimens OR patient is ineligible to receive potentially curative therapy
- Bidimensionally measurable or evaluable (e.g., bone marrow or infiltrative organ involvement) disease by physical exam or radiographic study
- No suspicion or evidence of lymphomatous meningitis
- PATIENT CHARACTERISTICS:
- Life expectancy ≥ 12 weeks
- ECOG performance status 0-4
- Not pregnant
- Negative pregnancy test
- Fertile patients must use medically prescribed contraception
- Absolute neutrophil count ≥ 1,000/mm\^3\*
- Platelet count ≥ 50,000/mm\^3\*
- Hemoglobin ≥ 8 g/dL\*
- Serum creatinine ≤ 2.0 mg/dL
- Total bilirubin ≤ 2.0 mg/dL\*\*
- Transaminases \< 5 times upper limit of normal\*\*
- No other malignancy within the past 5 years other than curatively treated non-metastatic skin cancer or in situ cervical carcinoma
- No history of significant or symptomatic cardiac arrhythmia
- No history of myocardial infarction
- No significant ventricular conduction abnormality by ECG or Holter monitoring, as evidenced by any of the following:
- Prior myocardial infarction
- Three or more premature ventricular contractions in a row
- No history of pancreatitis
- No history of recent gastrointestinal bleeding
- Must have heme-negative stool at enrollment NOTE: \*Cytopenias due to direct lymphomatous involvement allowed
- NOTE: \*\*Elevated due to direct lymphomatous involvement allowed
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 3 weeks since prior chemotherapy
- Recovered from prior chemotherapy (alopecia or anemia allowed)
- More than 3 weeks since prior investigational drugs
- No prophylactic antiemetics during course 1
- No other concurrent investigational drugs
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00293488
Start Date
January 1 2006
Last Update
June 23 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115