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New treatment option for Childhood Extracranial Germ Cell Tumor
Official title Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors
ClinicalTrials.gov ID: NCT03067181
What this study is testing
What is Bleomycin Sulfate?
Bleomycin Sulfate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for childhood extracranial germ cell tumor.
Also referred to as Blanoxan, BleMomycine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumor has spread outside of the organ in which it developed, it is considered metastatic.
- Phase 3: a large, late-stage study
- Time commitment: about 10 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT [all sites])
- Standard risk 1: Patients must be \< 11 years of age at enrollment
- Standard risk 2: Patients must be \>= 11 and \< 25 years of age at enrollment
- Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be...
- Histologic confirmation of a primary extracranial germ cell tumor in any of the categories outlined below is required of all patients at enrollment...
You likely can't join if
- Patients with any diagnoses not listed including:
- Stage I testicular cancer patients who have undergone primary RPLND (retroperitoneal lymph node dissection)
- Pure ovarian or extragonadal dysgerminoma/seminoma
- Pure mature teratoma
- Pure immature teratoma with alpha-fetoprotein (AFP) \>= 1000 ng/mL
- "Poor risk" GCT (age \>= 11 years old and COG stage IV ovarian, COG stage II- IV extragonadal, or IGCCC intermediate or poor risk testicular), or
See the full eligibility criteria
Who can join
- There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT [all sites])
- Standard risk 1: Patients must be \< 11 years of age at enrollment
- Standard risk 2: Patients must be \>= 11 and \< 25 years of age at enrollment
- Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with malignant germ cell tumor (stage II or higher).
- Histologic confirmation of a primary extracranial germ cell tumor in any of the categories outlined below is required of all patients at enrollment , with the following exceptions:
- Among patients were initially diagnosed with completely resected non-seminoma malignant GCT and later recur during observation post surgery, a diagnostic biopsy is not required for enrollment if elevated tumor markers...
- Patients may be enrolled without histologic or cytologic confirmation in the rare case where there are exceptionally raised tumor markers (alpha fetoprotein [AFP- ≥ 500 ng/mL or HCG ≥ 500 IU/L) and radiologic features...
- Low risk immature teratoma (IT); site: ovarian; stage: any; grade: any; histology: pure immature teratoma, mixed immature and mature teratoma, (may contain microscopic foci of yolk sac tumor [\< 3 mm], but no other...
- Low risk stage I non-seminoma MGCT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB, American Joint Committee on Cancer (AJCC) testicular stage IA, IB and IS; histology: must contain...
- Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; AJCC testicular stage IA IB, and IS; histology: must contain only seminoma; may contain immature/mature teratoma; may NOT contain yolk sac tumor...
- Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV, FIGO stage IC-IV, (International Germ Cell Consensus Classification [IGCCC] criteria DO NOT apply); histology: must contain at...
- Standard risk 2 (SR2)
- Site: ovarian; stage: COG stage II, III, and III-X, FIGO stage IC, II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) \>= 11 and \< 25
- Site: testicular; stage: COG stage II-IV, AJCC stage II, III, IGCCC good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma: must be IGCCC good risk...
- Notes:
- IGCCC criteria only apply to SR2 patients with a testicular primary tumor
- Use post-op tumor marker levels to determine IGCCC risk group
- Pure seminoma patients are not eligible for the standard risk arms of the study
- For the low risk stage I non-seminoma MGCT and the standard risk arms, components of yolk sac tumor, embryonal carcinoma, or choriocarcinoma can be mixed with other forms of GCT, such as seminoma or mature or immature...
- Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, 2 or 3; use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age
- Organ function requirements apply ONLY to patients who will receive chemotherapy (SR1 and SR2 patients)
- Adequate renal function defined as:
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 (within 7 days prior to enrollment) OR
- A serum creatinine based on age/sex as follows (within 7 days prior to enrollment): (mg/dL)
- 1 month to \< 6 months male: 0.4 female: 0.4
- 6 months to \< 1 year male: 0.5 female: 0.5
- 1 to \< 2 years male: 0.6 female: 0.6
- 2 to \< 6 years male: 0.8 female: 0.8
- 6 to \< 10 years male: 1 female: 1
- 10 to \< 13 years male: 1.2 female: 1.2
- 13 to \< 16 years: male: 1.5 female: 1.4
- \>= 16 years male: 1.7 female: 1.4
- Total bilirubin =\< 2 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
- Unless due to Gilbert's disease, malignant involvement of liver or vanishing bile duct syndrome
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 x upper limit of normal (ULN) (within 7 days prior to enrollment)
- Unless due to Gilbert's disease, malignant involvement of liver or vanishing bile duct syndrome
- Peripheral absolute neutrophil count (ANC) \>= 750/mm\^3 (within 7 days prior to enrollment) AND
- Platelet count \>= 75,000/mm\^3 (within 7 days prior to enrollment)
- Patients enrolling on the standard risk arms must be medically fit to receive protocol treatment and with no contraindications to protocol treatment
- Eligibility criteria to participate in the pilot study of the AYA-Hears instrument (patient reported outcomes [PROs] of ototoxicity) Note: participants in group 1 will not receive AGCT1531 protocol-directed therapy; all...
- \>= 11 and \< 25 years old at enrollment
- Able to fluently speak and read English
- Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor
- Followed for cancer or survivorship care at one of the following institutions:
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
- Dana Farber/Harvard Cancer Center
- Hospital for Sick Children
- Children's Hospital of Eastern Ontario
- Oregon Health and Science University
- Seattle Children's Hospital
- Yale University
What rules you out
- Patients with any diagnoses not listed including:
- Stage I testicular cancer patients who have undergone primary RPLND (retroperitoneal lymph node dissection)
- Pure ovarian or extragonadal dysgerminoma/seminoma
- Pure mature teratoma
- Pure immature teratoma with alpha-fetoprotein (AFP) \>= 1000 ng/mL
- "Poor risk" GCT (age \>= 11 years old and COG stage IV ovarian, COG stage II- IV extragonadal, or IGCCC intermediate or poor risk testicular), or
- Primary central nervous system (CNS) germ cell tumor
- Germ cell tumor with somatic malignant transformation
- Spermatocytic seminoma
- Patients must have had no prior systemic therapy for the current cancer diagnosis
- Patients must have had no prior radiation therapy with the exception of CNS irradiation of brain metastases; (this exception only applies to SR1 patients; any patients over age 11 with distant metastases to brain [stage...
- Patients with significant, pre-existing co-morbid respiratory disease that contraindicate the use of bleomycin are ineligible for the standard risk arms of the trial
- Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential; (this criteria...
- Lactating females who plan to breastfeed their infants; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients])
- Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation; (this criteria applies ONLY to patients who will receive...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Mobile, Alabama, United States
- Anchorage, Alaska, United States
- Kingman, Arizona, United States
- Mesa, Arizona, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Hot Springs, Arkansas, United States
- Little Rock, Arkansas, United States
- Anaheim, California, United States
- Arroyo Grande, California, United States
- Bellflower, California, United States
- Burbank, California, United States
- Carmichael, California, United States
- Downey, California, United States
- Duarte, California, United States
- Elk Grove, California, United States
- Fontana, California, United States
- La Jolla, California, United States
- Loma Linda, California, United States
+ 377 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Mobile, Alabama, United States; Anchorage, Alaska, United States; Kingman, Arizona, United States; Mesa, Arizona, United States; Phoenix, Arizona, United States and 391 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.