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Platinum-containing Compound
Chemotherapy and Stem Cell Transplant for Germ Cell Cancer
Phase 3
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No more than one prior line of chemotherapy for GCT (other than the 1 cycle of salvage chemotherapy as defined in the protocol). Definition of one line of chemotherapy: One line of therapy can in some cases consist of 2 different cisplatin-based treatment combinations, provided there is no disease progression between these two regimens. Prior treatment with carboplatin as adjuvant therapy is allowed, provided patients meet other eligibility criteria (e.g., the patient has also received 3-4 cycles of cisplatin-based chemotherapy). Prior treatment with 1-2 cycles of BEP or EP as adjuvant chemotherapy for early stage GCT is allowed, provided the patient also received 3-4 cycles of BEP or EP again at relapse. Patients treated with 3-4 cycles of VIP at relapse following 1-2 cycles of BEP/EP are not eligible as this would be considered more than 1 line of prior therapy. No prior treatment with high-dose chemotherapy (defined as treatment utilizing stem cell rescue). No prior treatment with TIP with the exception when given as a bridge to treatment on protocol for patients with rapidly progressive disease who cannot wait to complete the eligibility screening process. Only one cycle is allowed. No concurrent treatment with other cytotoxic drugs or targeted therapies. No radiation therapy (other than to the brain) within 14 days of day 1 of protocol chemotherapy except radiation to brain metastases, which must be completed 7 days prior to start of chemotherapy. No previous chemotherapy within 17 days prior to enrollment. A minimum of three weeks after the last day of the start of the previous chemotherapy regimen before the first day of chemotherapy on study protocol. Must have adequate recovery from prior surgery (eg, healed scar, resumption of diet). Age ≥ 14 years (≥ 18 years in Germany). ECOG Performance Status 0 to 2. Male gender. Required Initial Laboratory Values: Absolute Neutrophil Count (ANC) ≥ 1,500/mm^3. Platelet Count ≥ 100,000/mm^3. Calculated creatinine clearance ≥ 50 mL/min. Bilirubin ≤ 2.0 x upper limits of normal (ULN). AST/ALT ≤ 2.5 x upper limits of normal (ULN). No concurrent malignancy other than non-melanoma skin cancer, superficial noninvasive (pTa or pTis) TCC of the bladder, contralateral GCT, or intratubular germ cell neoplasia. Patients with a prior malignancy, but at least 2 years since any evidence of disease are allowed. Negative Serology (antibody test) for the following infectious diseases: Human Immunodeficiency Virus (HIV) type 1 and 2. Human T-cell Leukemia Virus (HTLV) type 1 and 2 (mandatory in US but optional in Canada and Europe). Hepatitis B surface antigen. Hepatitis C antibody. No late relapse with completely surgically resectable disease. Patients with late relapses (defined as relapse ≥ 2 years from the date of completion of the last chemotherapy regimen) whose disease is completely surgically resectable are not eligible. Patients with late relapses who have unresectable disease are eligible. No large (≥ 2 cm) hemorrhagic or symptomatic brain metastases until local treatment has been administered (radiation therapy or surgery). Treatment may begin ≥ 7 days after completion of local treatment. Patients with small (< 2 cm) and asymptomatic brain metastases are allowed and may be treated with radiation therapy and/or surgery concurrently with Arm A or cycles 1 and 2 of Arm B if deemed medically indicated. Radiation therapy should not be given concurrently with high-dose carboplatin or etoposide. No secondary somatic malignancy arising from teratoma (e.g., teratoma with malignant transformation) when it is actively part of the disease recurrence or progression.
Must have evidence of progressive or recurrent GCT (measurable or non-measurable) following one line of cisplatin-based chemotherapy, defined as meeting at least one of the following criteria: Tumor biopsy of new or growing or unresectable lesions demonstrating viable non-teratomatous GCT (enrollment on this study for adjuvant treatment after macroscopically complete resection of viable GCT is not allowed). In the event of an incomplete gross resection where viable GCT is found, patients will be considered eligible for the study. Consecutive elevated serum tumor markers (HCG or AFP) that are increasing. Increase of an elevated LDH alone does not constitute progressive disease. Development of new or enlarging lesions in the setting of persistently elevated HCG or AFP, even if the HCG and AFP are not continuing to increase.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years post-registration
Awards & highlights
Study Summary
This trial is studying how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumors that have returned after a period of improvement or did not respond to treatment.
Who is the study for?
This trial is for male patients aged 14 and above (18+ in Germany) with germ cell tumors that have come back or didn't respond to treatment. They should've had only one prior chemotherapy line, no high-dose chemo before, and be free from other cancers except certain non-aggressive types. Participants need good organ function, no recent treatments that conflict with the study drugs, and can't have fully resectable late relapse tumors.Check my eligibility
What is being tested?
The trial compares standard-dose chemo against high-dose chemo followed by a stem cell transplant in treating refractory/relapsed germ cell tumors. It tests if stopping cancer cells' growth through intense treatment plus stem cell support improves outcomes versus regular doses of paclitaxel, ifosfamide, cisplatin, carboplatin, etoposide phosphate.See study design
What are the potential side effects?
Chemotherapy may cause nausea, hair loss, fatigue; risk of infection due to low blood counts; kidney damage; nerve problems like numbness or tingling; hearing issues due to cisplatin. Stem cell transplant includes risks of graft failure and serious infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My germ cell tumor has grown or returned after one round of chemotherapy.
Select...
My cancer has been confirmed as GCT by a pathologist.
Select...
I've had 3-6 rounds of initial chemo with cisplatin. Up to 7 if I needed urgent treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years post-registration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years post-registration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
overall survival
Secondary outcome measures
Validation of International Prognostic Factor Study Group stratification system (eg, primary site, prior response, progression free interval)
number of participants with treatment-related adverse events as assessed by CTCAE v4.0
progression free survival
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm B: TI-CEExperimental Treatment7 Interventions
Patients will receive treatment for a total of 5 cycles.
Cycles 1-2 (1 cycle = 14 days)
paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 including premedication as defined in the protocol (eg, dexamethasone, diphenhydramine and H2 blocker)
ifosfamide 2000 mg/m^2 IV daily on Days 1-3 with mesna protection as defined in the protocol
G-CSF 10 µg/kg subcutaneously on Days 3-15 (cycle 1) and Days 3-14 (cycle 2) or pegylated G-CSF 6 mg subcutaneous on Day 4 or 6 (cycle 1) and Day 4 or 5 (cycle 2)
leukapheresis every 14 days, if there is an inadequate number of CD34+ cells/kg collected in cycle 1
Cycles 3-5 (1 cycle = 21 days)
carboplatin daily on Days 1-3
etoposide 400 mg/m^2 daily on Days 1-3
stem cell reinfusion on day 5
pegylated G-CSF 6 mg subcutaneously or G-CSF at approximately 5 µg/kg daily on Days 5-15
Patients may commence with each Arm B cycle provided they meet the criteria as defined in the protocol.
Group II: Arm A: TIPExperimental Treatment5 Interventions
Patients will receive treatment for 4 cycles administered every 21 days.
Cycles 1-4 (1 cycle = 21 days)
paclitaxel 250 mg/m^2 IV over 24 hours on Day 1 including premedication as defined in the protocol (eg, dexamethasone, diphenhydramine and H2 blocker)
ifosfamide 1500 mg/m^2 IV daily on Days 2-5 with mesna protection as defined in the protocol
cisplatin 25 mg/m^2 IV daily on Days 2-5
pegylated G-CSF 6 mg subcutaneous on Day 6 or 7 or G-CSF as defined in the protocol on Days 6-18
Patients may commence with each Arm A cycle provided they meet the criteria as defined in the protocol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
carboplatin
2010
Completed Phase 3
~4790
paclitaxel
1996
Completed Phase 3
~4310
ifosfamide
1999
Completed Phase 3
~2230
cisplatin
1997
Completed Phase 3
~3290
etoposide phosphate
2009
Completed Phase 3
~1630
G-CSF
2014
Completed Phase 4
~1610
Find a Location
Who is running the clinical trial?
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,218 Total Patients Enrolled
Institute of Cancer Research (ICR), United KingdomUNKNOWN
UNICANCEROTHER
221 Previous Clinical Trials
282,466 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My germ cell tumor has grown or returned after one round of chemotherapy.My cancer has been confirmed as GCT by a pathologist.I've had 3-6 rounds of initial chemo with cisplatin. Up to 7 if I needed urgent treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: TIP
- Group 2: Arm B: TI-CE
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What other scientific studies have been done using this same treatment?
"City of Hope Comprehensive Cancer Center first ran this trial in 1997 and there have been 2906 completed studies since. Currently, 1860 more trials are being conducted with many of them taking place in Commack, New jersey."
Answered by AI
What are some of the most well-known conditions that this medication helps to improve?
"This course of action is frequently used to treat lymphoma and non-Hodgkin. In addition, it can be used to manage other disorders like locally advanced non-small cell lung cancer, and initial cancer treatment."
Answered by AI
Does this medication have the government's seal of approval?
"The safety of this treatment falls on the third tier of our 1-3 scale because this is a Phase 3 trial. This indicates that not only is there some data supporting the efficacy of the treatment, but there are multiple rounds of data that support its safety."
Answered by AI
Are participants currently being enrolled in this research?
"Indeed, the clinicaltrials.gov website indicates that this study is still recruiting patients. The first posting was on March 1st, 2015, with the most recent update on September 25th, 2022. There are 63 different recruitment sites for this trial, and the goal is to enroll 420 patients in total."
Answered by AI
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