This study is NOT currently recruiting participants.
Number
001587-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Recruitment has not started Gender: Male & Female Min Age: 18 Years Max Age: 120 Years
Referral Letter Required
No
Population Exclusion(s)
Children;Pregnant Women;Neonates;Fetuses
Keywords
external beam radiation therapy (EBRT); abdominal adrenocortical carcinoma (ACC); preoperative radiation; Mitotane; Maximum Tolerated Dose (MTD); Surgical Resection; in-field intraabdominal progression-free survival (PFS); out-of-field intraabdominal progression-free survival (PFS); DNA damage repair markers; oxidative stress response
Recruitment Keyword(s)
None
Condition(s)
Adrenocortical carcinoma (ACC); recurrent adrenocortical carcinoma (ACC); recurrent abdominal adrenocortical carcinoma (ACC); Carcinoma, Adrenocortical; Carcinoma, Adrenal Cortical
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Radiation: Preoperative external beam radiation therapy (EBRT) Procedure/Surgery: Surgical resection
Supporting Site
National Cancer Institute
The eyeGENE(R) program is a research resource for inherited eye conditions which includes genotypic and phenotypic data, imaging, and a corresponding biobank of DNA samples from people with a variety of eye diseases. Since 2007 this registry has been helping researchers learn more about the genetic sources for many inherited eye diseases. These findings helped them create better treatments. Now researchers want to expand eyeGENE(R) to include more people for certain eye diseases.
Objective: To collect information and DNA samples for the study of eye diseases.
Primary objective
-To expand the current eyeGENE(R) data repository with targeted participant accrual
Secondary objectives
-To enhance recruitment for clinical trials and investigations in inherited eye diseases
-To establish genotype-phenotype correlations for rare eye diseases
Eligibility:
People of any age with certain eye diseases. These can include aniridia; Best disease; blue-cone monochromacy; corneal dystrophy; and disorders of pigmentation, such as albinism. Relatives unaffected by the eye disease of interest may also be needed.
Design:
Researchers will select participants based on their diagnosis. The data may include images and test results from eye exams.
Participants will provide a sample of saliva. They will receive a kit with written instructions. They will spit in a tube and mail it to the NIH.
Participants may be asked to provide a blood sample. The blood may be drawn at the NIH or at a local clinic.
The eyeGENE(R) repository will offer researchers data about the participants eye conditions. The data may include pictures of their eyes, results of genetic testing, and history of other diseases. Researchers will be able to see data such as age and gender, but they will not see names, dates of birth, or contact information.
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INCLUSION CRITERIA: -Age >= 18 years -Pathological confirmation of ACC by the Laboratory of Pathology, NCI. Note: Confirmation may be done from archival sample; fresh tissue is not required unless otherwise acquired for clinical purposes. -Measurable disease by RECISTv1.1. criteria at enrollment -Evidence of recurrent ACC amenable to surgical resection that can be performed at NIH Clinical Center (CC) -Must be suitable for external beam radiotherapy AND surgery in the opinion of the treating investigator (e.g., based on clinical history and imaging) -Participants with metastatic ACC outside the area(s) to be exposed to investigational treatments (e.g., liver parenchyma, lung[s], or bone[s]) must have disease that is amendable for a complete resection and/or catheter-based and/or radiation-based ablation. -Mitotane therapy- Participants may be receiving mitotane currently, have received it in the past, or never have received mitotane. However, participants will be evaluated in separate cohorts based on mitotane use and, as enrollment is sequential, not all participants may be eligible for the study at all times. Note: Participants with a history of mitotane use may continue on study at the discretion of the treating investigator. Participants will not initiate mitotane on study. -Participants must agree to undergo tumor biopsy of easily accessible tumor sites prior to study treatment. -Performance Status (ECOG) 0-2 -Adequate organ function, including: --Hemoglobin >= 9.0 gm/dL --ANC >= 1,500/mm^3 --Platelets >= 75,000/mm^3 --AST and ALT <= 3 x Upper Limit Normal (ULN) --Bilirubin <= 2 x ULN --Creatinine within normal institutional limits or creatinine clearance >60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal calculated using eGFR. -Sexually-active participants of childbearing potential must agree to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) prior to and for 4 months following cytoreduction surgery. -Breastfeeding participants must agree to discontinue breastfeeding until 4 months following cytoreductive surgery. -Ability of participant to understand and willingness to sign a written informed consent document -Participants must agree to co-enroll in tissue collection protocol 09C0242 "Prospective comprehensive molecular analysis of endocrine neoplasms." EXCLUSION CRITERIA: -Primary ACC or suspicious/indeterminate adrenal tumor without pathological confirmation -Prior abdominal radiation therapy -Participants who have received chemotherapy, immunotherapy, investigational therapy, or radiotherapy treatment within the last 4 weeks prior to starting treatment and/or have not recovered from toxicities to less than grade 2 CTCAE. -Infection requiring parenteral antibiotics -Suspected or proven ACC peritoneal metastasis -Pre-existing known or suspected radiation sensitivity syndromes -Prohibitive condition(s) to diagnostic laparoscopy -Participants who have an unacceptable risk for a major surgical procedure such as participants with high risks for major cerebro-cardiovascular (such as those who had doxorubicin exposure as based on screening echocardiogram and ECG) and pulmonary complications and those with estimated perioperative mortality greater than 15% per ACS NSQIP Surgical Risk calculator. -Participants receiving other investigational therapies -Participant pregnancy -Active systemic infections, coagulation disorders, or other major medical illnesses such as uncontrolled diabetes mellitus, uncontrolled hypertension (persistently grade 2 or worse), active severe cerebro-cardio-pulmonary diseases, and acute major organ dysfunction. -Acute intraabdominal conditions such as obstruction or peritonitis at the time of the evaluation or surgery. -Evidence at screening of or currently active CNS metastasis within 6 months of EBRT; participants with history of treated brain metastases with intracranial recurrence within 6 months prior to treatment. Note: Participants with any signs or symptoms suggestive of previously undiagnosed brain metastasis at screening or with a history of brain metastasis should receive imaging at screening; otherwise, imaging is not required. -HIV-positive participants with CD4 below 200 or who are not on anti-retroviral therapy -Participants who have a history of another primary malignancy from which the participant has been disease-free for < 3 years at the time of enrollment.
-Age >= 18 years
-Pathological confirmation of ACC by the Laboratory of Pathology, NCI. Note: Confirmation may be done from archival sample; fresh tissue is not required unless otherwise acquired for clinical purposes.
-Measurable disease by RECISTv1.1. criteria at enrollment
-Evidence of recurrent ACC amenable to surgical resection that can be performed at NIH Clinical Center (CC)
-Must be suitable for external beam radiotherapy AND surgery in the opinion of the treating investigator (e.g., based on clinical history and imaging)
-Participants with metastatic ACC outside the area(s) to be exposed to investigational treatments (e.g., liver parenchyma, lung[s], or bone[s]) must have disease that is amendable for a complete resection and/or catheter-based and/or radiation-based ablation.
-Mitotane therapy- Participants may be receiving mitotane currently, have received it in the past, or never have received mitotane. However, participants will be evaluated in separate cohorts based on mitotane use and, as enrollment is sequential, not all participants may be eligible for the study at all times. Note: Participants with a history of mitotane use may continue on study at the discretion of the treating investigator. Participants will not initiate mitotane on study.
-Participants must agree to undergo tumor biopsy of easily accessible tumor sites prior to study treatment.
-Performance Status (ECOG) 0-2
-Adequate organ function, including:
--Hemoglobin >= 9.0 gm/dL
--ANC >= 1,500/mm^3
--Platelets >= 75,000/mm^3
--AST and ALT <= 3 x Upper Limit Normal (ULN)
--Bilirubin <= 2 x ULN
--Creatinine within normal institutional limits or creatinine clearance >60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal calculated using eGFR.
-Sexually-active participants of childbearing potential must agree to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) prior to and for 4 months following cytoreduction surgery.
-Breastfeeding participants must agree to discontinue breastfeeding until 4 months following cytoreductive surgery.
-Ability of participant to understand and willingness to sign a written informed consent document
-Participants must agree to co-enroll in tissue collection protocol 09C0242 "Prospective comprehensive molecular analysis of endocrine neoplasms."
EXCLUSION CRITERIA:
-Primary ACC or suspicious/indeterminate adrenal tumor without pathological confirmation
-Prior abdominal radiation therapy
-Participants who have received chemotherapy, immunotherapy, investigational therapy, or radiotherapy treatment within the last 4 weeks prior to starting treatment and/or have not recovered from toxicities to less than grade 2 CTCAE.
-Infection requiring parenteral antibiotics
-Suspected or proven ACC peritoneal metastasis
-Pre-existing known or suspected radiation sensitivity syndromes
-Prohibitive condition(s) to diagnostic laparoscopy
-Participants who have an unacceptable risk for a major surgical procedure such as participants with high risks for major cerebro-cardiovascular (such as those who had doxorubicin exposure as based on screening echocardiogram and ECG) and pulmonary complications and those with estimated perioperative mortality greater than 15% per ACS NSQIP Surgical Risk calculator.
-Participants receiving other investigational therapies
-Participant pregnancy
-Active systemic infections, coagulation disorders, or other major medical illnesses such as uncontrolled diabetes mellitus, uncontrolled hypertension (persistently grade 2 or worse), active severe cerebro-cardio-pulmonary diseases, and acute major organ dysfunction.
-Acute intraabdominal conditions such as obstruction or peritonitis at the time of the evaluation or surgery.
-Evidence at screening of or currently active CNS metastasis within 6 months of EBRT; participants with history of treated brain metastases with intracranial recurrence within 6 months prior to treatment. Note: Participants with any signs or symptoms suggestive of previously undiagnosed brain metastasis at screening or with a history of brain metastasis should receive imaging at screening; otherwise, imaging is not required.
-HIV-positive participants with CD4 below 200 or who are not on anti-retroviral therapy
-Participants who have a history of another primary malignancy from which the participant has been disease-free for < 3 years at the time of enrollment.
Principal Investigator
Referral Contact
For more information: