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New treatment option for Anaplastic Kidney Wilms Tumor
Official title A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT
ClinicalTrials.gov ID: NCT04322318
What this study is testing
What is Carboplatin?
Carboplatin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for anaplastic kidney wilms tumor.
Also referred to as Blastocarb, Carboplat.
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 II trial studies how well combination chemotherapy works in treating patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed). Drugs used in chemotherapy regimens such as UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) and ICE/Cyclo/Topo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 30
You may be able to join if
- Patients with newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor must be enrolled on APEC14B1, consented to Part A - Eligibility Screening...
- Patients must be =\< 30 years old at study enrollment
- Patients with the following diagnoses are eligible for this study:
- Newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor as confirmed by central review
- Favorable histology Wilms tumor at first relapse. Relapsed FHWT patients must have previously achieved remission for their initial FHWT diagnosis to...
You likely can't join if
- Patients with a history of bilateral Wilms tumor (synchronous or metachronous)
- Patients with any uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, or symptomatic congestive heart...
- Relapsed FHWT patients who did not receive frontline chemotherapy (e.g., very low risk FHWT initially observed without chemotherapy) or received only...
- For patients with high-risk or very high-risk relapsed FHWT:
- Patients with renal tubular acidosis (RTA) as evidenced by serum bicarbonate \< 16 mmol/L and serum phosphate =\< 2 mg/dL (or \< 0.8 mmol/L) without...
- For stages 2-4 DAWT and standard-risk relapsed FHWT patients:
See the full eligibility criteria
Who can join
- Patients with newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor must be enrolled on APEC14B1, consented to Part A - Eligibility Screening, and have received an initial stratum assignment showing DAWT (if...
- Patients must be =\< 30 years old at study enrollment
- Patients with the following diagnoses are eligible for this study:
- Newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor as confirmed by central review
- Favorable histology Wilms tumor at first relapse. Relapsed FHWT patients must have previously achieved remission for their initial FHWT diagnosis to be eligible for this study. The relapse risk groups are defined as...
- Standard-Risk relapse: Patients who received two chemotherapy agents for frontline therapy; primarily actinomycin D and vincristine
- High-Risk relapse: Patients who received three chemotherapy agents for frontline therapy; primarily vincristine, actinomycin D and doxorubicin or vincristine, actinomycin D and irinotecan
- Very High-Risk relapse: Patients who received four or more chemotherapy agents as part of initial therapy; primarily regimen M or its variations
- Patients with newly diagnosed DAWT must have had histologic verification of the malignancy. For relapsed FHWT patients, biopsy to prove recurrence is encouraged, but not required
- Note: For relapsed FHWT patients, an institutional pathology report confirming favorable histology Wilms tumor (from relapse, if available, or from original diagnosis) must be available for upload prior to initiation of...
- Patients with newly diagnosed Stages 2 - 4 diffuse anaplastic Wilms tumor must be enrolled on AREN1921 within 2 weeks of the tumor-directed surgery or biopsy procedure that first confirms a diagnosis of DAWT, whether at...
- Patients with newly diagnosed DAWT who undergo upfront nephrectomy must have at least 1 lymph node sampled prior to study enrollment
- Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age
- Patients must have a life expectancy of \>= 8 weeks
- Diffuse Anaplastic Wilms Tumor: Patients with diffuse anaplastic histology must have had no prior systemic therapy, except in the following situations:
- Patients with diffuse anaplastic Wilms tumor who received no more than 12 weeks of pre nephrectomy chemotherapy for what was originally presumed to be favorable histology Wilms tumor, subsequently confirmed to be...
- Patients with diffuse anaplastic Wilms tumor who received no more than 6 weeks of chemotherapy following upfront biopsy, initiated within 14 days of biopsy, for presumed favorable histology Wilms tumor based on...
- Treatment consisting of vincristine/doxorubicin/cyclophosphamide initiated on an emergent basis and within allowed timing as described
- Note: Patients who received prior therapy for presumed favorable histology Wilms tumor, later identified to have diffuse anaplastic Wilms tumor as per above, must begin study treatment starting at cycle 3 (week 7) of...
- Relapsed Favorable Histology Wilms Tumor: Patients must not have received prior chemotherapy for their relapsed favorable histology Wilms tumor diagnosis. In addition, patients must have fully recovered from the acute...
- Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study
- Radiation therapy (RT): \>= 2 weeks (wks) must have elapsed for local palliative RT (small port); \>= 6 months must have elapsed if prior craniospinal RT or if \>= 50% radiation of pelvis; \>= 6 wks must have elapsed if...
- Patients may not be receiving any other investigational agents (within 4 weeks prior to study enrollment)
- Peripheral absolute neutrophil count (ANC) \>= 750/uL (performed within 7 days prior to enrollment)
- Platelet count \>= 75,000/uL (transfusion independent) (performed within 7 days prior to enrollment)
- Hemoglobin \>= 8.0 g/dL (may receive red blood cell [RBC] transfusions) (performed within 7 days prior to enrollment)
- Patients with high-risk or very high-risk relapsed FHWT who will be treated with regimen ICE/Cyclo/Topo, must have renal function assessed by creatinine clearance or radioisotope glomerular filtration rate (GFR) and...
- Creatinine clearance or radioisotope GFR \>= 60 mL/min/1.73 m\^2 (performed within 7 days prior to enrollment)
- Patients diagnosed with stage 2-4 DAWT or standard risk relapsed FHWT, who will be treated with regimen UH 3, may either obtain a creatinine clearance, radioisotope GFR (meeting the above criteria of GFR \>= 60...
- Age: Maximum Serum Creatinine (mg/dL)
- 1 month to \< 6 months: 0.4 (male and female)
- 6 months to \< 1 year: 0.5 (male and female)
- 1 to \< 2 years: 0.6 (male and female)
- 2 to \< 6 years: 0.8 (male and female)
- 6 to \< 10 years: 1 (male and female)
- 10 to \< 13 years: 1.2 (male and female)
- 13 to \< 16 years: 1.5 (male), 1.4 (female)
- \>= 16 years: 1.7 (male), 1.4 (female)
- Total bilirubin =\ 1.5 x ULN (performed within 7 days prior to enrollment)
- Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) \< 2.5 x upper limit of normal (ULN) for age or =\< 5 x...
- Shortening fraction of \>= 27% by echocardiogram, or ejection fraction of \>= 50% by radionuclide angiogram (obtained within 21 days prior to enrollment and start of protocol therapy)
What rules you out
- Patients with a history of bilateral Wilms tumor (synchronous or metachronous)
- Patients with any uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, or symptomatic congestive heart failure (defined as grade 2 or higher heart failure per Common Terminology...
- Relapsed FHWT patients who did not receive frontline chemotherapy (e.g., very low risk FHWT initially observed without chemotherapy) or received only one chemotherapy agent for frontline therapy
- For patients with high-risk or very high-risk relapsed FHWT:
- Patients with renal tubular acidosis (RTA) as evidenced by serum bicarbonate \< 16 mmol/L and serum phosphate =\< 2 mg/dL (or \< 0.8 mmol/L) without supplementation
- For stages 2-4 DAWT and standard-risk relapsed FHWT patients:
- Chronic inflammatory bowel disease and/or bowel obstruction
- Concomitant use of St. John's wort, which cannot be stopped prior to the start of trial treatment
- 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
- Lactating females who plan to breastfeed their infants
- Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
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
- Mesa, Arizona, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Downey, California, United States
- Loma Linda, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Madera, California, United States
- Oakland, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
+ 147 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 30 years. 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; Mesa, Arizona, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States and 161 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.