Pulmonary Suffusion in Controlling Minimal Residual Disease in Patients With Sarcoma or Colorectal Metastases

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT03965234
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Colorectal Cancer
  • Metastatic Bone Sarcoma
  • Metastatic Malignant Neoplasm in the Lung
  • Metastatic Soft Tissue Sarcoma
  • Metastatic Unresectable Sarcoma
  • Resectable Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cisplatin — DRUG
    Given via infusion
  • Isolated Chemotherapeutic Lung Perfusion — PROCEDURE
    Undergo pulmonary suffusion
  • Metastasectomy — PROCEDURE
    Undergo metastasectomy

Study Details

This phase I/II trial studies the side effects of pulmonary suffusion in controlling minimal residual disease in patients with sarcoma or colorectal carcinoma that has spread to the lungs. Pulmonary suffusion is a minimally invasive delivery of chemotherapeutic agents like cisplatin to lung tissues. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Pulmonary suffusion may also be useful in avoiding later use of drugs by vein that demonstrate no effect on tumors when delivered locally.

Key Dates

Start date
Jul 16, 2020
Status verified
Mar 2026
Primary completion
May 25, 2029
Completion
May 25, 2030

Study Design

Enrollment
99 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Prevention (cisplatin, metastasectomy)
    Patients undergo pulmonary suffusion consisting of cisplatin via infusion. Patients the undergo metastasectomy. Beginning 4-8 weeks, patients with unresectable sarcoma may receive chemotherapy.

Primary Outcome Measure

Incidence of local toxicities (Phase I) [ Time Frame: Up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263
Kenneth Seastedt, MD
[email protected]
716-845-8675
Kenneth Seastedt (PRINCIPAL_INVESTIGATOR)

Find similar trials in Buffalo, NY

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Roswell Park Cancer Institute· Buffalo, NY

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