Radiation Therapy and Concurrent Cisplatin Chemotherapy for Locally Advanced or Metastatic Malignant Melanoma

NCT00707161 | Terminated Phase 2 Results DMC

• 1 other identifier: HCI15461
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

The study is a prospective phase II trial of radiation therapy concurrent with cisplatin chemotherapy in the treatment of locally advanced or metastatic melanoma in patients who are deemed to require radiation therapy by treating physicians for purposes of local control or palliation. Eligibility criteria include pathologically confirmed melanoma. Patients will undergo radiation therapy (20 treatments of 2.5 Gy for a total of 50 Gy) concurrent with cisplatin chemotherapy.

Conditions

Cancer; Melanoma

Outcome Measures

Primary Outcomes (1)

• Response Rate of Melanoma Lesions

  Response rate of melanoma lesions was measured after treated with the trial agent.

  2005-2010

Study Arms (1)

All participants

EXPERIMENTAL

Radiation: Radiation Therapy; Drug: Cisplatin; Procedure: Surgical resection

Interventions

Radiation Therapy RADIATION

Radiation therapy will be delivered concurrent with cisplatin chemotherapy as outlined in table 2. Radiation therapy dose will be 50 Gy (2.5 Gy per day, 5 days per week, for 20 treatments).

All participants

Cisplatin DRUG

Cisplatin dose will be 100 mg/m2 given i.v. every 3 weeks for a total of 2 doses (days 1 and 22) during radiation.

Also known as: chemotherapy

All participants

Surgical resection PROCEDURE

Surgical resection of residual (or recurrent) melanoma for cure or for palliation may be performed following chemoradiation if deemed appropriate by the treating physicians (surgical resection may be planned following pre-operative chemoradiation or may be performed for salvage due to inadequate response to chemoradiation or for relapse following chemoradiation). Surgical resection will not be performed until at least 4 weeks following chemoradiation (unless deemed emergent by the treating physicians).

Also known as: surgery

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed study-specific consent form prior to registration.
• Pathologically confirmed malignant melanoma.
• Measurable melanoma lesion deemed to require radiation by treating physicians for purposes of local control or palliation. The lesion may be the primary melanoma, a nodal metastasis, or a distant metastasis. Recurrent lesions are allowed.
• Lesion has to be measurable clinically or radiographically in 2 dimensions.
• Karnofsky Performance Scale (KPS) \> 70.
• Laboratory values
• White blood cells (WBC) \> 3000/mm3
• Absolute granulocyte count \> 1,500
• Platelets \> 100,000/mm3
• Total bilirubin \< 2.0 x institutional upper limit of normal
• AST or ALT (aminotransferase/alanine aminotransferase) \< 2.5 x institutional upper limit of normal
• Serum calcium \< 1.3 x institutional upper limit of normal
• Serum creatinine \< 1.5 mg/dL or Creatinine clearance \> 50 cc/min,calculated as follows: CCr = 0.85 x (140-age) x (weight in kg) 72 x serum creatinine in mg/dL

You may not qualify if:

• Systemic therapy for malignant melanoma within one month preceding trial enrollment.
• Prior irradiation to the planned field.
• Concomitant chemotherapy (in addition to cisplatin) or biologic therapy is allowed.
• Significant infection or other co-existent medical condition which would prevent the use of full dose chemotherapy.
• Pre-existing sensory neuropathy (CTC 3.0 ≥ Grade II)
• Pregnancy or lactation.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (2)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

MeSH Terms

Conditions

Neoplasms; Melanoma

Interventions

Radiotherapy; Cisplatin; Drug Therapy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Limitations and Caveats

Early termination due to low enrollment.

Results Point of Contact

• Title: Dennis Shrieve, MD
• Organization: Huntsman Cancer Institute

dennis.shrieve@hci.utah.edu

801-581-8793

Study Officials

• Dennis Shrieve, MD

  Huntsman Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2008
• First Posted: June 30, 2008
• Study Start: September 1, 2005
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: March 31, 2017
• Results First Posted: April 4, 2012

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)