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Safety Study of rhuMAb 2C4 to Treat Advanced Solid Tumors



Safety Study of rhuMAb 2C4 to Treat Advanced Solid Tumors

For Condition: Neoplasms
Status: No longer recruiting
Sponsor(s): Genentech ,
Synopsis: The purpose of this Phase I study is to test the safety of rhuMAb 2C4 to see what effects (good and bad) it has on patients with certain types of cancer, and also to find the highest dose of rhuMAb that can be given without causing severe side effects. All study participants will be assigned to specific group to evaluate different dosages of rhuMAb 2C4. The study is scheduled to run for up to one year depending on how patients respond to the study treatment.
Details:
Eligibility:
Study Type:  Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA - Signed informed consent - Age >= 18 years old - ECOG performance status of 0 or 1 - Life expectancy of >= 12 weeks - Histologically documented, incurable, locally advanced or metastatic solid malignancies - Disease progression on or after standard effective therapy or a malignancy for which there is no standard therapy - At least one bi-dimensionally measurable lesion >= 2 cm (>= 1 cm on spiral CT scan) - HER2-negative status as defined by fluorescence in situ hybridization (FISH) testing (only for subjects with breast cancer) - Use of an effective means of contraception for women of childbearing potential - Granulocyte count of >=1500/mL, platelet count of >= 100,000/mL, and hemoglobin of >= 9 g/dL - Serum bilirubin less than or equal to the upper limit of normal (ULN) and alkaline phosphatase, AST, and ALT <= 2.5 x ULN (ALT and AST <= 5 x ULN for subjects with liver metastases; alkaline phosphatase <= 4 x ULN for subjects with liver or bone metastases) - Serum creatinine less than or equal to ULN or creatinine clearance of >= 60 mL/min - International normalized ratio (INR) of <1.3 and activated partial thromboplastin time (aPTT) of <1.5 x ULN
Total Enrollment: 30

Location and Contact Information:

Overall Study Official:
AnnLowe,  Study Director,  Genentech

Cedars-Sinai Medical Center
Los Angeles,  California,  90211
United States
 


Additional Information:
Study ID Numbers:  TOC2297g; 
Study Start Date: November 2001
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027027

Other Neoplasms Studies:
1. Phase I and Pharmacokinetic Trial of Paclitaxel (Taxol) Given as a 3-Hour Infusion in Pediatric Patients with Refractory Malignancy

2. Study to Determine the Maximum Tolerated Dose of LErafAON in Patients with Advanced Solid Tumors

3. Study to Determine Maximum Tolerated Dose of LErafAON Combined with Radiotherapy in Patients with Advanced Malignancies

4. A Phase I Trial of 5-Flouroucacil Given with 776C85 (GW776) and Low-Dose Leucovorin in Adult Patients with Solid Tumors

5. Safety and Tolerability Study of Farnesyl Protein Transferase Inhibitor in Combination with Gemcitabine and Cisplatin in Advanced Cancer

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