Please assess the completion status of the following clinical trial:

Trial Title: Irinotecan and Temozolomide in Treating Young Patients With Recurrent Neuroblastoma

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
DISEASE CHARACTERISTICS:~* Histologically confirmed neuroblastoma AND/OR demonstration of tumor cells in the bone marrow with increased urinary catecholamines at initial diagnosis~  * Patients with elevated catecholamines only are not eligible~* Meets 1 of the following criteria:~  * Recurrent disease following aggressive, multidrug, frontline chemotherapy, defined as chemotherapy given with ≥ 2 agents, including an alkylating agent and a platinum-containing compound~ * Resistant/refractory disease during aggressive, multidrug, frontline chemotherapy~* Must meet 1 of the following criteria for documentation of disease:~  * Unidimensionally measurable tumor ≥ 20 mm by MRI (Magnetic Resonance Imaging), CT scan (Computed Tomography), or x-ray OR ≥ 10 mm by spiral CT scan within 4 weeks prior to study entry~    * Patients with residual stable tumor upon completion of frontline therapy must undergo biopsy to document presence of a viable neuroblastoma~   * If the measurable target lesion was previously radiated, a biopsy must be performed ≥ 4 weeks after radiation was completed AND the biopsy must demonstrate viable neuroblastoma~ * MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical) with positive uptake at ≥ 1 site within 4 weeks prior to study entry~    * Patients with residual stable MIBG-positive lesions upon completion of frontline therapy must undergo biopsy to document presence of viable neuroblastoma~   * If the patient has only 1 MIBG-positive lesion, and that lesion was previously radiated, a biopsy must be performed ≥ 4 weeks after radiation was completed AND the biopsy must demonstrate viable neuroblastoma~ * Bone marrow with tumor cells on routine morphology (not by neuron-specific enolase staining only) of bilateral aspirate and/or biopsy on 1 bone marrow sample within 2 weeks prior to study entry~* No extensive marrow disease~* No myelodysplastic syndrome~PATIENT CHARACTERISTICS:~* Karnofsky performance status (PS) 50-100% (for patients \> 16 years of age) OR Lansky PS 50-100% (for patients ≤ 16 years of age)~* Life expectancy ≥ 8 weeks~* Absolute neutrophil count ≥ 750/mm\^3~* Platelet count ≥ 75,000/mm\^3 (transfusion independent)~* Hemoglobin ≥ 8.5 mg/dL (transfusion allowed)~* Creatinine adjusted according to age as follows:~  * No greater than 0.4 mg/dL (≤ 5 months)~ * No greater than 0.5 mg/dL (6 months -11 months)~ * No greater than 0.6 mg/dL (1 year-23 months)~ * No greater than 0.8 mg/dL (2 years-5 years)~ * No greater than 1.0 mg/dL (6 years-9 years)~ * No greater than 1.2 mg/dL (10 years-12 years)~ * No greater than 1.4 mg/dL (13 years and over \[female\])~ * No greater than 1.5 mg/dL (13 years to 15 years \[male\])~ * No greater than 1.7 mg/dL (16 years and over \[male\]) OR~* Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min~* Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age~* ALT \< 2.5 times ULN for age~* Not pregnant or nursing~* Negative pregnancy test~* Fertile patients must use effective contraception~* Seizure disorder allowed provided seizures are well controlled on non-EIAC medication~* No active diarrhea or uncontrolled infection~* No other malignancy, including secondary malignancy~PRIOR CONCURRENT THERAPY:~* See Disease Characteristics~* Prior front-line therapy (e.g., surgery, chemotherapy, immunotherapy, radiotherapy, or retinoids) allowed~* Recovered from prior therapy~* More than 4 weeks since prior radiation therapy to the site of any lesion that will be identified as a target lesion to measure tumor response~* At least 2 weeks since prior myelosuppressive therapy (4 weeks for nitrosourea)~* At least 1 week since prior therapy with an antineoplastic biologic agent or retinoid~* At least 1 week since prior growth factors~* At least 1 week since prior and no other concurrent anticancer agents~* At least 1 week since prior and no concurrent enzyme-inducing anticonvulsants (EIAC), including phenytoin, phenobarbital, valproic acid, or carbamazepine~  * Concurrent gabapentin or levetiracetam allowed~* Concurrent palliative radiation therapy to sites not used to measure tumor response allowed~* No prior allogeneic stem cell transplantation (SCT)~  * Prior autologous SCT allowed~* No prior second-line chemotherapy for relapsed or refractory disease~* No concurrent immunomodulating agents~  * Concurrent steroids for transfusion/infusion reactions or for treatment of edema associated with CNS lesions allowed

- Gender: ALL
- Minimum Age: None
- Maximum Age: 21 Years
- Healthy Volunteers: f

Study Arms:
- Disease measurable by CT or MRI scan (Irinotecan/Temozolomide) (Type: EXPERIMENTAL): Measurable by CT scan (Computed Tomography) or MRI scan (Magnetic Resonance Imaging). Patients receive irinotecan hydrochloride IV (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- Disease eval by bone marrow or MIBG (Irinotecan/Temozolomide) (Type: EXPERIMENTAL): Evaluation by bone marrow or MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical). Patients receive irinotecan hydrochloride IV (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete