Status:
WITHDRAWN
Pilot Study of MGd + High-dose MTX-Based Chemoimmunotherapy + RT for Newly Dx PCNSL
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Pharmacyclics LLC.
Conditions:
Brain and Central Nervous System Tumors
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab...
Detailed Description
OBJECTIVES: Primary * Determine the safety and efficacy of motexafin gadolinium (MGd) combined with high-dose methotrexate-based chemotherapy and radiotherapy in patients with newly diagnosed primar...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed primary CNS lymphoma (PCNSL) diagnosed by brain biopsy, CSF cytology, or vitreal biopsy
- Newly diagnosed disease
- Patients who have an inconclusive biopsy or who are not candidates for biopsy may be eligible provided they have a typical cranial MRI or CT scan (defined as the presence of hypo-, iso- or hyperdense parenchymal contrast-enhancing, usually homogeneously) mass lesion(s) and meet at least one of the following criteria:
- Positive cerebrospinal fluid cytology for lymphoma or a monoclonal lymphocyte population as defined by cell surface markers
- Biopsy of the vitreous or uvea demonstrating non-Hodgkin lymphoma
- Measurable (defined as reproducibly measurable disease in two perpendicular dimensions on radiologic study) or evaluable disease
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-3
- Life expectancy ≥ 8 weeks
- ANC ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Bilirubin ≤ 2.0 mg
- SGOT ≤ 2 times upper limit of normal
- Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance \> 50 cc/min
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 6 months after completion of study therapy
- HIV negative
- No other active primary malignancy with the exception of basal cell carcinoma of the skin or cervical carcinoma in situ
- PRIOR CONCURRENT THERAPY:
- No prior cranial irradiation
- No prior chemotherapy for CNS lymphoma
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00734773
Start Date
November 1 2008
Last Update
May 18 2012
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.