Acute Changes in Endothelial Function in Germ Cell Tumor Patients Treated With Cisplatin and Untreated Germ Cell Tumor Controls

Memorial Sloan Kettering Cancer Center (MSK)

Status: Active, not recruiting

Conditions: Germ Cell Cancer

Treatments: Other: Endo-PAT2000 testing

Study type: Observational

Funder types: Other

Identifiers

NCT01453660

11-140

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

44 participants in 2 patient groups

Cisplatin-Based Chemotherapy Group

Description:

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.

Treatment:

Other: Endo-PAT2000 testing

Other: Endo-PAT2000 testing

Surgery-Only Group

Description:

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.

Treatment:

Other: Endo-PAT2000 testing

Other: Endo-PAT2000 testing