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| Sponsor: | Case Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00023790 |
Purpose
RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. This may be effective treatment for skin cancer and cancer that is metastatic to the skin.
PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy in treating patients who have either squamous cell or basal cell carcinoma of the skin or solid tumors metastatic to the skin.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Head and Neck Cancer Lymphoma Metastatic Cancer Non-melanomatous Skin Cancer Sarcoma |
Drug: silicon phthalocyanine 4 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Trial of PC 4-PDT (NSC 676418) for Cutaneous Malignancies |
| Enrollment: | 3 |
| Study Start Date: | August 2001 |
| Study Completion Date: | February 2006 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive silicon phthalocyanine 4 (Pc 4) IV over 2 hours on day 1 followed by light therapy over 30-60 minutes on day 2. Treatment repeats in 6 weeks for a total of 2 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of Pc 4 and a fixed dose of light until the maximum tolerated dose (MTD) of Pc 4 is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD for Pc 4 is determined, additional patients are treated with a fixed dose of Pc 4 (2 dose levels below the MTD) and escalating doses of light until the MTD is determined. The MTD of light is defined as above.
Patients are followed at 6 weeks (or 8 weeks if treated lesion on lower extremity has not healed) and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 25-30 patients will be accrued for this study annually.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed tumor for which no potential curative therapy exists (e.g., surgery, radiotherapy, or systemic chemotherapy)
The following tumor types are eligible:
Cutaneous nodular metastatic breast carcinoma lesion with loco-regional cutaneous, soft tissue, or chest wall involvement
Stage IA-IIB or IVA cutaneous T-cell lymphoma (CTCL)
Bidimensionally measurable disease
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Ohio | |
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Study Chair: | Scot C. Remick, MD | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
More Information
| Responsible Party: | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00023790 History of Changes |
| Other Study ID Numbers: | CWRU1Y97, U01CA062502, P30CA043703, CWRU-1Y97, NCI-T99-0007, CASE-1Y97 |
| Study First Received: | September 13, 2001 |
| Last Updated: | August 23, 2011 |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
|
stage IV breast cancer recurrent breast cancer stage I cutaneous T-cell non-Hodgkin lymphoma stage II cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma basal cell carcinoma of the skin squamous cell carcinoma of the skin recurrent skin cancer classic Kaposi sarcoma immunosuppressive treatment related Kaposi sarcoma AIDS-related Kaposi sarcoma recurrent Kaposi sarcoma stage IV squamous cell carcinoma of the lip and oral cavity stage IV basal cell carcinoma of the lip |
stage IV verrucous carcinoma of the oral cavity stage IV mucoepidermoid carcinoma of the oral cavity stage IV adenoid cystic carcinoma of the oral cavity recurrent squamous cell carcinoma of the lip and oral cavity recurrent basal cell carcinoma of the lip recurrent verrucous carcinoma of the oral cavity recurrent mucoepidermoid carcinoma of the oral cavity recurrent adenoid cystic carcinoma of the oral cavity stage IV squamous cell carcinoma of the oropharynx stage IV lymphoepithelioma of the oropharynx recurrent squamous cell carcinoma of the oropharynx recurrent lymphoepithelioma of the oropharynx stage IV squamous cell carcinoma of the nasopharynx stage IV lymphoepithelioma of the nasopharynx recurrent squamous cell carcinoma of the nasopharynx |
|
Breast Neoplasms Skin Neoplasms Head and Neck Neoplasms Lymphoma Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Sarcoma Neoplasms by Site Breast Diseases Skin Diseases Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Neoplastic Processes Pathologic Processes Neoplasms, Connective and Soft Tissue Silicon Phthalocyanine Silicon phthalocyanine Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Radiation-Sensitizing Agents Antimalarials Antiprotozoal Agents |