Brentuximab Vedotin in Relapsed/Refractory Germ Cell Tumors
Stopped: lack of funding/ benefit
United States18 participantsStarted 2016-03-09
Plain-language summary
This is a Phase II study to evaluate the activity of brentuximab vedotin in relapsed/refractory non-seminomatous germ cell tumors (NSGCT).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 18 years at the time of informed consent.
✓. Patients with histologically or serologically confirmed relapsed/refractory non-seminoma germ cell tumor, (i.e., embryonal carcinoma, choriocarcinoma, or yolk sac tumors) including female GCT and primary mediastinal NSGCT.
✓. Patients must have progressed after prior high dose chemotherapy (HDCT) treatment, been deemed not to be a candidate for high dose chemotherapy or refused high-dose chemotherapy, and be considered incurable by other standard therapies including further chemotherapy or surgery. There is no maximum allowable number of previous therapies.
✓. A \>25% increase in the products of perpendicular diameters of measurable tumor masses during prior therapy which are not amenable to surgical resection.
✓. The presence of new tumors which are not amenable to surgical resection.
✓. An increase in AFP or beta-hCG (two separate determinations at least one week apart are required if rising tumor markers are the only evidence of failure).
✓. Patients must have evidence of recurrent or metastatic carcinoma by one or more of the following:
✓. Patients with primary medistinal non seminomatous germ cell tumor are eligible if they have received first line platinum based chemotherapy and their recurrence is not amenable to surgical resection based on the treating physician expert opinion.
Exclusion criteria
✕. Patients with pure seminoma.
✕
What they're measuring
1
Objective Response (Percent of Patients With Complete Response or Partial Response)
✕. Chemotherapy within 2 weeks of initiating study treatment. There is no maximum allowable number of previous therapies.
✕. Major surgery within 3 weeks of starting study treatment. There is no minimum time requirement for minor procedures such as biopsy or vascular access placement.
✕. Radiation within 2 weeks of starting study treatment.
✕. ≥ Grade 3 neuropathy at the time of enrollment.
✕. Pregnancy or breast-feeding.
✕. Previous treatment with any anti-CD30 directed therapy.