Overview

This trial is active, not recruiting.

Condition germ cell cancer
Treatments endo-pat2000 testing
Sponsor Memorial Sloan Kettering Cancer Center
Start date October 2011
End date October 2017
Trial size 44 participants
Trial identifier NCT01453660, 11-140

Summary

Cisplatin is one of the most common chemotherapy drugs used to treat many different cancers, including germ cell tumors (GCT). Cisplatin is very effective in treating GCT, but there are side effects. One of the possible long-term side effects of cisplatin is thought to be heart disease. The way that cisplatin causes heart disease is not well understood. One possibility is that cisplatin may damage the inside layer of blood vessels called the endothelium. The purpose of this study is to measure changes in the endothelium that happen when patients with GCT get cisplatin chemotherapy and to compare these changes with a group of patients not receiving chemotherapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
GCT patients who are planned to start cisplatin-based chemotherapy will be identified within the genitourinary oncology service clinics and offered inclusion in the trial.
endo-pat2000 testing
Endo-PAT2000 testing is done six times during the study. Baseline Assessment Time 1 Cycle 1, Day 1 (Pre-chemotherapy)Time 2 Cycle 1, Day 1 (After 1st dose of cisplatin), Time 3 Cycle 1, Day 2 (Before second cisplatin dose of cycle 1), Time 4 Cycle 1, Day 5 (After last cisplatin dose of cycle 1), End-of-Study Assessment Time 5 (14-34 weeks from Time 1; e.g., 1-12 weeks following completion of the last cycle of first-line chemotherapy) Long-Term Follow Up Assessment Time 6 (24-30 months from Time 1)
GCT patients who have been treated with surgery and who do not require chemotherapy or radiation will be used as a comparison group to confirm that there is not a significant change in endothelial function among GCT patients treated with surgery alone.
endo-pat2000 testing For any patients in Surgery-Only Group who relapse & enroll in the the
Time 1: A baseline assessment will be performed in the fasting state including Endo-PAT2000, vital signs, waist circumference, fasting blood draw, & urine sample. This will be considered Day 1 of the study for this group of patients. Time 2 (2-5 hours from Time 1): Two to five hours after Time 1, patients will undergo assessment of blood pressure & heart rate, including orthostatics & Endo-PAT2000 testing. Time 5 -- End of Study visit (14-34 weeks from Time 1): At a time point 14 to 34 weeks later than Time 1 patients will undergo study testing in the fasting state. This includes Endo-PAT2000 testing, vital signs including orthostatics, waist circumference, fasting blood draw, & urine sample. The Surgery-Only Group will not have any assessment at Time 3 (Day 2) or Time 4 (Day 5) due to logistical concerns. Long-Term Follow Up Assessment Time 6 (24-30 months following Time 1)

Primary Outcomes

Measure
Measure the endothelial reactivity (PAT-RH) in both groups
time frame: 15 minutes

Secondary Outcomes

Measure
Identify sociodemographic
time frame: 2 years
Identify comorbid health conditions
time frame: 2 years
Measure PAT-RH index
time frame: 2 years

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: Cisplatin-Based Chemotherapy Group - Histologically-proven diagnosis of GCT - Male - Age ≥18 - No prior exposure to chemotherapy or radiation - Planned to receive 3-4 cycles of cisplatin-based chemotherapy Surgery-Only Group - Histologically-proven diagnosis of GCT Male - Age ≥18 - Surgical management of GCT performed less than 90 days before start of study (includes orchiectomy and primary retroperitoneal lymph node dissection (RPLND)) - No prior exposure to chemotherapy or radiation Exclusion Criteria: Cisplatin-Based Chemotherapy Group - Prior exposure to chemotherapy or radiation - Known diagnosis or history of being diagnosed with vasculitis, autonomic dysfunction, coronary artery disease, or collagen-vascular disease Surgery-Only Group - Prior exposure to chemotherapy or radiation - Planned for non-surgical management with chemotherapy or radiation. - Known diagnosis or history of being diagnosed with vasculitis, autonomic dysfunction, coronary artery disease, or collagen-vascular disease.

Additional Information

Official title A Pilot Study Measuring Acute Changes in Endothelial Function in Germ Cell Tumor Patients Treated With Cisplatin and Untreated Germ Cell Tumor Controls
Principal investigator Darren Feldman, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.