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Radiation Therapy in Combination With Indinavir / Ritonavir (Crixivan / Norvir) for the Treatment of Brain Metastases: a Randomized Phase II Study


Phase 2
N/A
N/A
Open (Enrolling)
Both
Cancer

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Trial Information

Radiation Therapy in Combination With Indinavir / Ritonavir (Crixivan / Norvir) for the Treatment of Brain Metastases: a Randomized Phase II Study


OBJECTIVES:

- Compare the efficacy, in terms of time to treatment failure at CNS level and 4-months
treatment failure rate, in patients with brain metastases treated with external-beam
radiotherapy in combination with indinavir sulfate and ritonavir versus external-beam
radiotherapy alone.

- Prospectively investigate the efficacy of a potentially antiangiogenic agent, indinavir
sulfate.

- Investigate the antineoplastic activity of indinavir sulfate in combination with
ionizing radiation in cancer patients with metastatic disease to the brain.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo radiotherapy to the brain once daily, 5 days a week for 2 weeks
(10 doses total). Patients also receive oral indinavir sulfate and oral ritonavir twice
daily for 35 days beginning at day 1 of radiotherapy.

- Arm II: Patients undergo radiotherapy to the brain once daily, 5 days a week for 2
weeks (10 doses total).

Patients complete quality of life questionnaires, including QOL-30 and the Mini Mental
Status Examination, at baseline, 2 weeks after completion of radiotherapy, and at 1 and 3
months after completion of study treatment.

After completion of study treatment, patients are followed periodically for at least 4
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic cancer with brain metastases

- Biopsy of brain metastases is not required

- All cancer types allowed, except for the following:

- Prostatic adenocarcinoma

- Sarcoma

- Melanoma

- Germ cell carcinoma,

- Small-cell lung cancer

- Measurable disease by MRI of the brain

- Not requiring immediate surgical decompression (may qualify after surgery, if
remaining measurable brain lesions)

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2 (corresponds to recursive partitioning analysis groups I
or II)

- Life expectancy > 4 months

- Able to understand the aim of trial and to comply with follow-up

- No HIV seropositivity

PRIOR CONCURRENT THERAPY:

- Prior dexamethasone allowed provided it is tapered before initiation of study
radiotherapy

- Not requiring cytotoxic treatment within 3 months after study radiotherapy

- At least 1 week since prior and no concurrent phenytoin

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Time to treatment failure in the brain (TTF) as determined by the radiological response rate

Safety Issue:

No

Principal Investigator

Ilja Ciernik, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oncology Institute of Southern Switzerland

Authority:

Unspecified

Study ID:

CDR0000587517

NCT ID:

NCT00637637

Start Date:

September 2007

Completion Date:

Related Keywords:

  • Cancer
  • tumors metastatic to brain
  • stage IV adenoid cystic carcinoma of the oral cavity
  • stage IV adrenocortical carcinoma
  • stage IV adult Burkitt lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult Hodgkin lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV adult T-cell leukemia/lymphoma
  • stage IV anal cancer
  • stage IV basal cell carcinoma of the lip
  • stage IV bladder cancer
  • stage IV borderline ovarian surface epithelial-stromal tumor
  • stage IV breast cancer
  • stage IV childhood anaplastic large cell lymphoma
  • stage IV childhood Hodgkin lymphoma
  • stage IV childhood large cell lymphoma
  • stage IV childhood liver cancer
  • stage IV childhood lymphoblastic lymphoma
  • stage IV childhood small noncleaved cell lymphoma
  • stage IV chronic lymphocytic leukemia
  • stage IV colon cancer
  • stage IV cutaneous T-cell non-Hodgkin lymphoma
  • stage IV esophageal cancer
  • stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • stage IV follicular thyroid cancer
  • stage IV gastric cancer
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV hypopharyngeal cancer
  • stage IV inverted papilloma of the paranasal sinus and nasal cavity
  • stage IV laryngeal cancer
  • stage IV lip and oral cavity cancer
  • stage IV lymphoepithelioma of the nasopharynx
  • stage IV lymphoepithelioma of the oropharynx
  • stage IV mantle cell lymphoma
  • stage IV marginal zone lymphoma
  • stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
  • stage IV mucoepidermoid carcinoma of the oral cavity
  • stage IV mycosis fungoides/Sezary syndrome
  • stage IV nasopharyngeal cancer
  • stage IV non-small cell lung cancer
  • stage IV oropharyngeal cancer
  • stage IV ovarian epithelial cancer
  • stage IV pancreatic cancer
  • stage IV papillary thyroid cancer
  • stage IV paranasal sinus and nasal cavity cancer
  • stage IV penile cancer
  • stage IV prostate cancer
  • stage IV rectal cancer
  • stage IV renal cell cancer
  • stage IV salivary gland cancer
  • stage IV small lymphocytic lymphoma
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the nasopharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV endometrial carcinoma
  • stage IV verrucous carcinoma of the larynx
  • stage IV verrucous carcinoma of the oral cavity
  • stage IV vulvar cancer
  • stage IV Wilms tumor
  • stage IVB cervical cancer
  • stage IVB vaginal cancer
  • metastatic adult malignant fibrous histiocytoma of bone
  • metastatic childhood malignant fibrous histiocytoma of bone
  • metastatic gastrointestinal carcinoid tumor
  • metastatic parathyroid cancer
  • metastatic pheochromocytoma
  • metastatic squamous neck cancer with occult primary squamous cell carcinoma
  • metastatic squamous neck cancer with occult primary
  • metastatic transitional cell cancer of the renal pelvis and ureter
  • disseminated neuroblastoma
  • unspecified adult solid tumor, protocol specific
  • unspecified childhood solid tumor, protocol specific
  • tongue cancer
  • Neoplasm Metastasis

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