New chemo combo aims to beat standard treatment for tough germ cell tumors
NCT ID NCT01873326
First seen Jul 06, 2026 · Last updated Aug 07, 2026 · Updated 3 times
Summary
This trial tests whether a new combination of chemotherapy drugs (paclitaxel, ifosfamide, and cisplatin, or TIP) works better than the current standard treatment (bleomycin, etoposide, and cisplatin, or BEP) for people with intermediate- or poor-risk germ cell tumors. These are cancers that start in the testicles or ovaries and are harder to treat. The study enrolls adults with newly diagnosed tumors and measures how well the tumors shrink or disappear after treatment. The goal is to find a more effective option for patients who do not respond well to standard therapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- paclitaxel, ifosfamide, cisplatin, mesna, bleomycin, etoposide
- What this could lead to
- If TIP proves more effective, it could become a new standard treatment for hard-to-treat germ cell tumors, improving cure rates.
- What could go wrong
- This is a phase 2 trial with a small number of participants, so results may not be definitive. Both regimens have significant side effects, and TIP may not outperform BEP.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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92 people
The number who actually took part.
- Start date
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Jun 2013
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients ≥ 18 years of age. * Patients with newly diagnosed GCT * Pathology confirmation of GCT histology at MSKCC or a collaborating treating institution. In exceptional circumstances, patients without pathological diagnosis may be included in the study following discussion with the national principal investigator, Dr. Feldman,(or national Co-PI or MSKCC Co-PI if the national PI is unavailable) if they meet the one of the following criteria: * Patients with a testicular mass (detected clinically and/or by ultrasound), and/or mediastinal or retroperitoneal lymphadenopathy or pineal tumor AND elevated serum tumor markers (HCG and/or AFP). Patients with elevated LDH only will not be included without pathological confirmation of GCT since LDH is a nonspecific marker for GCT and could potentially be elevated in other malignancies such as lymphomas. This is because patients may present with a clinical scenario consistent with GCT (elevated serum tumor markers, testicular mass and retroperitoneal lymphadenopathy) with a concurrent life-threatening oncologic emergency that require immediate treatment. In this case, initial treatment without biopsy confirmation is usually recommended and tissue confirmation may be obtained after initiating therapy. * Patients must have measurable or evaluable disease. * Patients must be classified as having intermediate or poor-risk germ cell tumor, as follows: * Intermediate-risk (Modified\*) a) Testis or retroperitoneal primary NSGCT with lymph node and/or lung metastasis but without non-pulmonary visceral metastasis AND any of the following pretreatment serum tumor marker (STM) values: i. Lactate dehydrogenase (LDH) from 3 to \<10 x ULN (\*This differs from the original IGCCCG criteria which includes patients with LDH from 1.5 to 10 x ULN). ii. Serum human chorionic gonadotrophin (HCG) from 5,000 to \< 50,000 MIU/mL iii. Serum alpha-fetoprotein (AFP) from 1,000 to \<10,000 ng/mL b) Seminoma histology regardless the primary site or serum tumor markers with any non-pulmonary visceral metastasis (liver, bone, brain, etc). * Poor-risk (any of the following): 1. Testis or retroperitoneal NSGCT primary with non-pulmonary visceral metastasis (liver, bone, brain, etc) regardless the STM values. 2. Mediastinal NSGCT primary site of disease regardless the presence/absence of visceral metastasis or STM values. 3. Testis or retroperitoneal NSGCT primary without non-pulmonary visceral metastasis but with poor-risk STM values: * i. LDH ≥ 10 x ULN * ii. HCG ≥ 50,000 MIU/mL * iii. AFP ≥ 10,000 ng/mL * Patients who received prior radiation therapy (RT) for treatment of germ cell tumor are eligible for this study as long as there is evidence of progressive disease determined by tumor markers or other sites of metastases outside of the radiated site. Radiation must be completed prior to starting chemotherapy with the exception of brain metastases where chemotherapy and radiation can be given concurrently. Toxicity from radiation must have recovered to grade 1 or less prior to initiating chemotherapy. * Patients must have recovered from prior surgery based on treating physician's discretion. * Patients of reproductive potential must agree to use effective contraception during the period of therapy * Signed informed consent. * Diffusion lung capacity for carbon monoxide (DLCO) adjusted for hemoglobin ≥60% predicted, except if related to high volume metastatic GCT to the lungs in which case there is no minimum DLCO requirement. In some cases, patients may not be able to undergo PFT testing due to the severity of their presentation. such as those with high volume lung metastases or tumor-related pain (from large mediastinal masses, pleural disease, etc.) limiting their ability to complete PFTs. Even when PFTs can be completed in these cases, patients will still be eligible if the low DLCO can be attributed directly to the patient's disease (e.g., large mediastinal mass) rather than intrinsic lung disease. Since there is no minimum DLCO for these patients, under these extraordinary circumstances, this will be allowed. Most patients in this situation will be expected to receive disease-stabilizing chemotherapy. An unadjusted DLCO may be used in place of the DLCO adjusted for hemoglobin in certain situations as per institutional policy. For example, MSKCC policy is to not adjust the DLCO for hemoglobin when the hemoglobin is ≥ 14.6 g/dL for males and ≥ 13.4 g/dL for females. In these cases, the unadjusted DLCO must be \>60% predicted. * Laboratory criteria for protocol entry (obtained ≤ 14 days before initiation of therapy): * WBC ≥ 3000/UL and Platelet count ≥ 100,000/UL * Serum creatinine ≤ 1.5 mg/dL or estimated GFR (by Cockcroft-Gault) ≥50mL/min or 12 or 24 hour urine creatinine clearance ≥ 50 mL/min, unless renal insufficiency is due to tumoral ureteral obstruction in which case eligibility will be determined by national the principal investigator (or national co-PI or MSKCC co-PI if the national PI is unavailable) with notification of the MSKCC IRB. * AST/ALT ≤ 3 x ULN and total bilirubin ≤ 2.0 x ULN. In the setting of metastatic disease to the liver, AST/ALT may be ≤5x ULN and total bilirubin ≤2.5 x ULN. If a patient is known or suspected to have Gilbert's disease, total bilirubin up to ≤2.5 x ULN is allowed. Exclusion Criteria: * Any prior chemotherapy. The only exception will be patients with a history of stage I seminoma treated with adjuvant carboplatin for 1 or 2 cycles. * Concurrent treatment with any cytotoxic therapy. * Known concurrent malignancy (except for non-melanoma skin cancer). * Patients known to be HIV positive and receiving HAART. * Presence of an active infection. Patients with fever assessed to be "tumor fever" but without active evidence of infection (e.g. blood cultures are negative) are eligible. In addition, patients who have an infection but without evidence of fever for 48 hours on antibiotics will be eligible. * Inability to comply with the treatment protocol or to undergo prespecified follow-up tests for safety or effectiveness. * Pregnant patients are ineligible
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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Memorial Sloan Kettering Bergen (Follow-up Only)
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
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Stanford University Medical Center
Stanford, California, 94305-5408, United States
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University of Chicago
Chicago, Illinois, United States
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University of North Carolina
Chapel Hill, North Carolina, 27514, United States
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
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University of Southern California
Los Angeles, California, 90033, United States
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