Brentuximab Vedotin in Relapsed/Refractory Germ Cell Tumors

Status Terminated

Clinical Trial Summary

This is a Phase II study to evaluate the activity of brentuximab vedotin in relapsed/refractory non-seminomatous germ cell tumors (NSGCT).

Clinical Trial Description

Primary Objective To determine the anti-tumor efficacy of brentuximab vedotin in relapsed/ refractory NSGCT.

Secondary Objectives

1. To determine the progression free survival in patients with relapsed/ refractory NSGCT treated with brentuximab vedotin.

2. To determine the overall survival of patients with relapsed/ refractory NSGCT treated with brentuximab vedotin.

3. To determine the safety and tolerability of brentuximab vedotin in this patient population.

Eligible patients will be divided into two cohorts, those who are CD30 positive and those who are CD30 negative/unknown. Both groups will be treated similarly and in parallel but analyzed separately. CD30 status may be unknown in the unlikely case of tumor-marker-only relapse or when a fresh tumor biopsy is not feasible, and archival tumor tissue is not obtainable despite efforts to do so. These patients will be included in the CD30 negative cohort for analysis purposes, since statistically NSGCT are more likely to be CD30 negative. The number of such patients with unknown CD30 status should not exceed 5 patients.

Eligible patients will be treated with brentuximab vedotin at 1.8 mg/kg IV every 3 weeks (maximum dose of 180 mg) indefinitely until disease progression, unacceptable toxicity, or study closure.Eligible patients with grade 2 peripheral neuropathy at enrollment will be treated with brentuximab vedotin at 1.2 mg/kg IV every 3 weeks (maximum dose of 180 mg) indefinitely until disease progression, unacceptable toxicity, or study closure. Response to treatment will be assessed clinically with history, physical exam and tumor markers measurement (BHCG and AFP) on day 1 of each cycle and with CT scans after cycle 2, 4, and every 4 cycles thereafter while receiving treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02689219
Study type	Interventional
Source	Indiana University
Contact
Status	Terminated
Phase	Phase 2
Start date	March 9, 2016
Completion date	January 23, 2019

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT00772694` - Sorafenib Monotherapy in Inoperable/Recurrent Germ Cell Carcinoma Refractory to Chemotherapy	Phase 2
Completed	`NCT00705094` - Cardiac Function and Cardiovascular Risk Profile in Testicular Cancer Patients	N/A
Terminated	`NCT00531687` - Trial of Paclitaxel, Gemcitabine and Cisplatin in Patients With Relapsing Germ Cell Cancer	Phase 2
Completed	`NCT00216801` - Relationship of Ochratoxin A to Upper Urologic Cancers	N/A
Terminated	`NCT00820287` - Identification of Predictive Markers for Testis Cancer in a Population of Men With High Risk	N/A
Active, not recruiting	`NCT03142802` - Low-Dose CT - Stage I Testicular Cancer	N/A
Recruiting	`NCT03232541` - The Effects of Acupuncture and the Therapist´s Communication on Chemotherapy Induced Nausea and Vomiting	N/A
Completed	`NCT03557177` - Clinical Characterisation of the Vascular Effects of Cis-platinum Based Chemotherapy in Patients With Testicular Cancer
Active, not recruiting	`NCT01783145` - Shared Care Follow-up After Chemotherapy for Testicular Cancer
Recruiting	`NCT05611307` - Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Completed	`NCT02573584` - Vascular Fingerprint Validation Study
Recruiting	`NCT05670938` - Follow-up After Surgery for Testicular Cancer
Recruiting	`NCT02994758` - Development of Diagnostics and Treatment of Urological Cancers	N/A
Completed	`NCT02991209` - Study of Testosterone vs Placebo in Testicular Cancer Survivors	Phase 2/Phase 3
Completed	`NCT02602041` - Knowledge and Attitudes Regarding Healthy Lifestyle and Health Behavior Change in Cancer Patients and Their Partners; A Pilot Study
Completed	`NCT02092740` - REtrospective Study of TESTIcular CAncer Patients at the University Magdeburg	N/A
Completed	`NCT01482741` - Understanding Patient Perspectives on the Risks of Ionizing Radiation Used for Medical Imaging	N/A
Active, not recruiting	`NCT01242072` - Intravenous Palifosfamide-tris in Combination With Etoposide and Carboplatin in Patients With Malignancies	Phase 1
Completed	`NCT01242631` - Everolimus for Patients With Relapsed/Refractory Germ Cell Cancer	Phase 2
Completed	`NCT01135849` - B-Receptor Signaling in Cardiomyopathy	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.