Brain and Central Nervous System Tumors | Gemcitabine, Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Progressive or Relapsed Metastatic Germ Cell Tumors
Brain and Central Nervous System Tumors research study
What is the primary objective of this study?
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, paclitaxel, ifosfamide, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine when given together with paclitaxel, ifosfamide, and cisplatin, and to see how well they work in treating patients with progressive or relapsed metastatic germ cell tumors.
Who is eligible to participate?
DISEASE CHARACTERISTICS: - Meets the following criteria: - Histologically confirmed extracranial primary germ cell cancer, seminoma, or nonseminoma - Unresectable metastatic disease - No completely resected cancer - Rising serum markers (i.e., alpha-fetoprotein and human chorionic gonadotropin) on sequential measurement or biopsy-proven unresectable germ cell cancer - In first relapse after a single prior cisplatin-containing combination chemotherapy - Patients with late relapse (i.e., > 2 years post initial chemotherapy) should be considered for surgery rather than chemotherapy, if technically feasible - No patients with cerebral metastases alone - Progressive cerebral and systemic disease may be considered for this study, provided cranial irradiation is also considered as a component of care PATIENT CHARACTERISTICS: - Medically and psychologically fit to receive this intensive chemotherapy schedule - WBC > 3.5 times 10^9/L - Platelet count > 130 times 10^9/L - Glomerular filtration rate ≥ 50 mL/min (as determined by 24 hour creatinine clearance or nuclear medicine technique) - Fertile patients must use effective contraception - No other prior malignancy except successfully treated nonmelanoma skin cancer or superficial bladder cancer - No prior allergic reactions to cisplatin or other platinum compounds PRIOR CONCURRENT THERAPY: - See Disease Characteristics
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Brain and Central Nervous System Tumors
Extragonadal Germ Cell Tumor
Testicular Germ Cell Tumor
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Paclitaxel, gemcitabine, cisplatin, ifosfamideDay 1 Dexamethasone sodium phosphate 25mg I/V ) before Chlorphenamine 10mg I/V 30 - 60 mins ) paclitaxel Ranitidine 50mg I/V ) Paclitaxel - 175 mg m2 I/V in 500ml normal saline over 3 hours Gemcitabine - 1200mg per m2 I/V in 500ml normal saline over 30 mins Days 1-5 Cisplatin 20mg per m2 in 1 litre normal saline over 4 hours 2 litres normal saline over 16 hours, each litre containing 10 mmol MgSO4 and 20mmol KCL. If urine output is insufficient (less than 600ml per 6 hours) or if excessive weight gain (greater than 2kg) 100 - 200ml 10% mannitol should be used. Alternatively, low dose frusemide (20mg I/V) can be used. Days 2 - 6 Ifosfamide 1G per m2 + MESNA 0.5G m2 in 500 ml normal saline over 1 hour after the cisplatin infusion. MESNA 0.5G m2 to be included in first 1 litre post cisplatin hydration bag Pegylated G-CSF will be given on day 7 as an alternative to daily G-CSF.
Start Date: November 2006
Phase: Phase 1/Phase 2
Primary Outcome: Maximum tolerated dose of gemcitabine hydrochloride when administered with TIP chemotherapy comprising paclitaxel, ifosfamide, and cisplatin with growth factor support (phase I)
Study sponsors, principal investigator, and references
Principal Investigator: G. Mead, MD
Lead Sponsor: University of Southampton
Collaborator: University Hospital Southampton NHS Foundation Trust